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1.  Balloon Kyphoplasty 
Executive Summary
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
2.  AB175. Three-piece penile prosthesis implantation under local anesthesia 
Translational Andrology and Urology  2014;3(Suppl 1):AB175.
Malleable penile prosthesis could be inserted by local anesthesia only, but there are few reports available regarding 3-piece penile prosthesis implantation under local anesthesia due to some difficulty in inserting reservoir. It would be very advantageous if 3-piece penile prosthesis could be implanted by local anesthesia only at private clinic as a one stop service. The authors developed a local anesthetic method that could implant 3-piece penile prosthesis easily as a day surgery at private clinic.
Material and methods
A total of 45 cases (38 fresh, 7 revision) were implanted under local anesthesia from Oct 2013 to Jul 2014.
Methods of local anesthesia
(I) Premedication--alprazolam 0.25 mg po; (II) IV fluid and monitoring pulse and po2; (III) tramadol hcl 50 mg 1 or 2 ampl iv; (IV) midazolam 1 or 2 mg iv; (V) pudendal n block 1.5% lidocaine 5 cc instill on both side each; (VI) ilioinguinal n block—1.5% lidocaine 5 cc; (VII) penile block dorsal n and scrotal skin—1% lidocaine.
A total of 45 patients (38 fresh, 7 revision) completed the study. The mean age of the patients was 62 years (range, 35 to 81 years). The types of implanted prosthesis were AMS CXR 35 and CX 10. The length of implanted prosthesis was from 14 to 20 cm (mean 16 cm). The response during surgery estimated by three grades: (I) very comfortable and smooth, no pain complaint at all (30 patients); (II) mild pain sometimes but well tolerated (13 patients); (III) marked pain and screaming (2 patients). Malignant tachycardia was observed in one case. No case was converted to general anesthesia. Barovac drainwas removed between 24 to 48 hours. Patients were discharged on that day (15 patients) or next day (30 patients).
Three-piece penile prosthesis could be implanted easily under local anesthesia as a one stop service at private clinic.
PMCID: PMC4708329
Penile prosthesis implantation; local anesthesia
3.  Dorsal penile nerve block with ropivacaine versus intravenous tramadol for the prevention of catheter-related bladder discomfort: study protocol for a randomized controlled trial 
Trials  2015;16:596.
Catheter-related bladder discomfort (CRBD) is common in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, we will enroll male patients undergoing elective surgery with urinary catheterization after anesthetic induction and compare the efficacy of a dorsal penile nerve block (DPNB) and intravenous tramadol for the prevention of CRBD.
This trial is a prospective, open-label, randomized controlled trial that will test the superiority of a dorsal penile nerve block with 0.33 % ropivacaine to the use of intravenous tramadol 1.5 mg/kg for CRBD prevention. A total of 60 male patients undergoing elective surgery with urinary catheterization after anesthetic induction will be randomized to receive either DPNB with 0.33 % ropivacaine (DPNB group) or intravenous tramadol 1.5 mg/kg (TRAM group) after the completion of surgery but before extubation. The primary outcome is the incidence and severity of CRBD. Secondary outcomes include Visual Analog Score (VAS) for postoperative pain, number of patients requiring sulfentanil after operation, acceptance of an indwelling urinary catheter after extraction of the catheter, and postoperative side effects, which include postoperative nausea/vomiting (PONV), vertigo, sedation, drowsiness, and dry mouth.
For CRBD prevention, this trial is planned to test the superiority of a dorsal penile nerve block with 0.33 % ropivacaine to the use of intravenous tramadol 1.5 mg/kg. The results will provide new insight into the mechanism of CRBD and new clinical practice for the prevention of CRBD.
Trial registration
The registration number is NCT01721031, which was assigned by the National Institutes of Health Clinical Trials Registry ( on 27 October 27.
PMCID: PMC4696154  PMID: 26715519
Randomized controlled trial; Dorsal penile nerve block; Catheter-related bladder discomfort
4.  Impact of Age, Gender and Anesthesia Modality on Post-Operative Pain in Total Knee Arthroplasty Patients 
Optimizing pain control following total knee arthroplasty is of utmost importance to the immediate post-operative course. Various anesthesia modalities are available, but studies comparing multiple anesthesia modalities, patient age, and sex are limited.
The purpose of our study was to examine the impact of patient age, gender, and perioperative anesthesia modality on postoperative pain following primary total knee arthroplasty.
443 patients who underwent primary total knee arthroplasty by 14 surgeons with some combination of general anesthesia, spinal anesthesia, femoral nerve block, and intrathecal morphine were identified. Anesthesia route and type, length of surgery, post-operative patient-reported pain measures using the Visual Analog Scale, opioid consumption, and length of hospital stay were recorded for each patient and used to compare differences among study groups.
No significant differences were noted between anesthesia groups with regards to postoperative pain or length of hospital stay. Patients receiving spinal anesthesia and femoral nerve block without intrathecal morphine were significantly older than other groups. Patients receiving general anesthesia required significantly more daily intravenous morphine equivalents than patients receiving spinal anesthesia. Patients receiving spinal anesthesia with femoral nerve block and intrathecal morphine consumed the least amount of morphine equivalents. When comparing males and females among all groups, females had significantly higher pain ratings between 24-36 and 24-48 hours postoperatively.
Although no significant differences were noted on pain scores, patients who received spinal anesthesia with intrathecal morphine and femoral nerve block used less narcotic pain medication than any other group. Females reported significantly higher pain between 24-48 hours post-op compared with males but not significantly greater anesthetic usage.
Level of Evidence
Level III, Therapeutic Study, (Retrospective Comparative study)
PMCID: PMC4492143  PMID: 26361449
Total knee arthroplasty; Pain control; Anesthesia; Gender
5.  Efficacy of dexamethasone on postoperative analgesia in children undergoing hypospadias repair 
Background and Objective:
Management of post operative pain in children undergoing hypospadiasis repair, accounts for optimized surgery outcomes and improved patients’ satisfaction. Thus, various studies have widely investigated the best approaches for the pain management. In this study our aim was to determine the effect of dexamethasone in combination with penile nerve block on the postoperative pain and complications in the children undergoing hypospadias surgery.
In this randomized double-blind placebo controlled trial, after obtaining informed consent from parents or legal guardians, 42 children undergoing surgical treatment of hypospadias were randomized in two groups to receive either IV dexamethasone 0.5 mg/kg (n=23) or placebo (normal saline) (n=19) during the operation. Penile block was performed in both groups using Bupivacaine 0.5% (1mg/kg) at the end of the procedure. By the end of the operation, FLACC (Face, Leg, Activity, Cry, Consolability) pain score was assessed as the primary outcome of the study. Secondary outcomes includes timing and episodes of rescue medication consumption, post operative nausea \vomiting and bleeding. All the outcomes were assessed in the recovery room and after 2, 6, 12, and 24 hours.
The median of FLACC pain scores at the recovery room and 2, 6, 12, and 24 hours post operation was 2, 1, 1, 1, and 2 for the dexamethasone group and 8, 8, 7, 7, and 8 for the placebo group respectively. This were significantly different (P<0.000). The median time of first rescue medication consumption was 8 hours post operation for the dexamethasone group and three hours for the placebo group which was significantly different (z= 4.57, p<0.000). The maximum episode of post operative rescue medication consumption in dexamethasone group was 4 episodes in only one patient and the minimum was one episode in 11 patients. In comparison numbers in placebo group were five episodes in seven patients and three episodes in four patients. The result indicated that there was statistically significant difference between two groups in terms of episodes of rescue medication consumption (Chi2= 31.4, p<0.000).
Single dose of intravenous dexamethasone (0.5 mg/kg) in combination with penile block decreased the post operative pain measures, and total post operative analgesic requirement. It also increased the onset of the first analgesic requirement compared to penile block alone.
PMCID: PMC4795851  PMID: 27022359
Dexamethasone; Post operative pain; Hypospadias
6.  Long-acting liposomal bupivacaine decreases inpatient narcotic requirements in men undergoing penile prosthesis implantation 
Turkish Journal of Urology  2016;42(4):230-234.
A new extended-release bupivacaine suspension bupivacaine (ERSB) delivers 3 days of local anesthetic and has been shown to reduce pain and narcotic usage in some patient groups but this issue is largely unstudied in urologic surgery.
Material and methods
We performed a single-surgeon retrospective chart review of the patients who underwent penile prosthesis implantation. Pain scores and standardized morphine equivalent (ME) dose data were collected during 23 hour- observation period. Subjects who received ERSB were compared with those who received standard bupivacaine or no local anesthesia.
In a study population of 37 patients, those who received (n=13), and did not receive (n=24) ERSB were grouped, respectively. The groups were comparable demographically. ME was used 3.2 fold more frequently in the non-ERSB group (18.0, and 5.6 for non-ERSB, and ESRB groups, respectively (p=0.04). Mean overall pain scores were 3.8/10 for ERSB and 3.9/10 for non-ERSB group, respectively. Per patient medication cost for the control, and ERSB groups were $5.16 and $285.54, respectively.
The use of a new ERSB in penile prosthesis implants did lead to reduced narcotic consumption with comparable postoperative pain control to the non-ERSB group. However, the cost of the ERSB ($285/dose) may be prohibitive for its use.
PMCID: PMC5125735  PMID: 27909614
Erectile dysfunction; liposomal bupivacaine; local anesthetic; penile prosthesis
7.  Grafting techniques for Peyronie’s disease 
Peyronie’s disease (PD) is a benign fibrotic condition of the penile tunica albuginea. PD can be associated with penile pain, curvature, shortening, and erectile dysfunction (ED). The predominant and most bothersome symptom in affected patients is penile curvature, which can lead to inability to have sexual intercourse. In such cases, surgical correction of the curvature may be required. Plication techniques to correct curvature can cause penile shortening and therefore are generally reserved for curvatures <60°. Penile prosthesis implantation with simultaneous correction of curvature by various means is recommended in PD patients with ED not responding to medical therapy. Grafting techniques are the preferred surgical treatment in patients with penile curvatures >60°, short penis, or hourglass deformity. Patients scheduled for grafting surgery are required to have satisfactory erectile rigidity preoperatively. There are various grafting materials that can be used for closure of the tunica albuginea defect following plaque incision/excision. Both autologous and non-autologous grafts have been used for PD reconstructive surgery, and each graft has its advantages and disadvantages. Novel grafting materials are presented and discussed in this review. A major advantage of the available “off-the-shelf” grafts is that there is no harvesting from a donor site and, thus, morbidity is reduced, and operative times are minimized. Further investigations in regard to tissue-engineered grafts to improve surgical handling and postoperative outcomes are ongoing. Surgeon experience, careful patient selection, patient preference and type of penile deformity affect the choice of graft. This review summarizes the literature within the past 5 years regarding grafting techniques in PD. Surgical outcomes and limitations of grafting techniques are reported. A major objective of this review is dedicated to preoperative considerations and indications for grafting procedures, with the aim to improve surgical outcomes and increase patient satisfaction. Proper postoperative management of patients after incision/excision and grafting is important to avoid early and long-term complications and unwanted outcomes. This review provides an overview of recent advances and recommendations in regard to rehabilitation strategies after grafting procedures. Adequate preoperative patient counseling, careful patient selection, appropriate indications, and postoperative management is key to optimal surgical outcomes with high satisfaction rates after grafting techniques in PD surgery.
PMCID: PMC4893511  PMID: 27298780
Grafting techniques; grafts; Peyronie’s disease (PD); surgical outcomes; surgical therapy
8.  Pharmacologically induced erect penile length and stretched penile lengh are both good predictors of post-inflatable prosthesis penile length 
Inflatable penile prosthesis (IPP) remains the gold standard for the surgical treatment of refractory erectile dysfunction; however, current literature to aid surgeons on how best to counsel patients on their postoperative inflated penile length is lacking. The aim of this study was to identify preoperative parameters that could better predict postoperative penile length following insertion of an IPP. Twenty men were enrolled in a prospective study examining penile lengths before and after IPP surgery. Patients with Peyronie’s disease were excluded from this analysis. Baseline preoperative characteristics, including body mass index, history of hypertension, diabetes, Sexual Health Inventory for Men scores and/or prior radical prostatectomy were recorded. All patients underwent implantation with a three-piece inflatable Coloplast penile prosthesis. We compared stretched penile length to pharmacologically induced erect lengths. Postoperatively, we measured inflated penile lengths at 6 weeks and assessed patients’ perception of penile size at 12 weeks. The median (± interquartile range) stretched penile length and pharmacologically induced erect penile length was 15 (± 3) and 14.25 (± 2) cm, respectively (P = 0.5). Median post-prosthesis penile length (13.5 ± 2.13 cm) was smaller than preoperative pharmacologically induced length (P = 0.02) and preoperative stretched penile length (P = 0.01). The majority of patients (70%) had a decrease in penile length (median loss 0.5 ± 1.5 cm); however, this loss was perceptible by 43% of men. Stretched penile length and pharmacologically induced erect penile length were equally good predictors of postoperative inflated length (Spearman’s correlation 0.8 and 0.9, respectively). Pharmacologically induced erect penile length and stretched penile lengths are equal predictors of post-prosthesis penile length. The majority of men will experience some decrease in penile length following prosthesis implantation; however <50% report a subjective loss of penile length.
PMCID: PMC4342061  PMID: 24430278
erectile dysfunction; penile length; penile prosthesis; stretched penile length
9.  Capsular Contraction with S-Shaped Deformity of Nonlength-Expanding Inflatable Penile Prosthesis Cylinders: Management and Prevention Strategies 
Sexual Medicine  2013;1(2):95-98.
Capsular contraction (CC) occurring with inflatable penile prosthesis (IPP) reservoirs has been reported by urologists as a cause of autoinflation. The concept of CC occurring around IPP cylinders has not been studied.
Herein we report a case of CC occurring with nonlength-expanding IPP cylinders, resulting in an S-shaped deformity.
Main Outcome Measures
We sought to report a novel cause of S-shaped deformity in patients after IPP surgery.
We reviewed a recent clinical case and conducted a literature review on capsular scar formation in prosthetic surgery. We also conducted a literature review of the inflammatory cascade related with prosthetic surgery.
Capsular contracture of nonlength-expanding cylinders resulting in S-shaped deformity has not been previously reported. The role of certain inflammatory markers seems to play a common role of capsular contracture in the penis and other prosthetic implantation sites.
Capsular contractures around the cylinders of an IPP can cause deformity, even in patients who have appropriately sized, nonlength-expanding cylinders. A better understanding is needed regarding the mechanical properties of the tunica albuginea and the inflammatory cascade associated with penile implant surgery. This case represents an argument for early and aggressive postoperative inflation of the IPP. Future studies should evaluate the role of inflammation modulators as adjuvant therapy after IPP surgery. Karpman E and Henry G. Capsular contraction with S-shaped deformity of nonlength-expanding inflatable penile prosthesis cylinders: Management and prevention strategies. Sex Med 2013;1:95–98.
PMCID: PMC4184503  PMID: 25356293
Penile Prosthesis; S-Shaped Deformity; Capsular Contraction; Erectile Dysfunction; Penis; Surgery
10.  Lengthening strategies for Peyronie’s disease 
Loss of penile length is a common complaint of men with Peyronie’s disease (PD), both before and after corrective intervention, which has a significant negative effect on patient quality of life. We sought to identify and describe the methods by which penile length can be preserved or increased. We conducted an extensive, systematic literature review, based on a search of the PUBMED database for articles published between 1990 and 2015. Articles with the key words “Peyronie’s disease”, “penile length” and/or “penile lengthening” were reviewed if they contained subjective or objective penile length outcomes. Only English-language articles that were related to PD and penile size were included. We found no evidence in the literature that medical therapy alone increases penile length. Classic inflatable penile prosthesis (IPP) placement, plication procedures, and the Nesbit procedure appear likely to maintain or decrease penile length. Plaque incision (PI) and grafting appears likely to maintain or increase penile length, but is complicated by risk of post-operative erectile dysfunction (ED). There are several surgical procedures performed concomitantly with IPP placement that may be suitable treatment options for men with comorbid ED, and consistently increase penile length with otherwise good outcomes concerning sexual function. These include the subcoronal penile prosthesis (scIPP), Egydio circumferential technique, the sliding technique, the modified sliding technique (MoST), and the multiple slice technique (MuST). In addition, adjuvant therapies such as penile traction therapy (PTT), post-operative inflation protocols, suspensory ligament relaxation, lipectomy, and adjuvant medical therapy for glans engorgement appear to increase subjective and/or objective penile length for men at high risk of decreased penile length after PD surgery. Considering the psychological burden of length loss in men with PD, providers with adequate volume and expertise should attempt, if possible, to maintain or increase penile length for men undergoing surgical intervention. There are several evidence-based, safe, and effective ways to increase penile length for these men and multiple emerging adjuvant therapies that may help ensure adequate length.
PMCID: PMC4893519  PMID: 27298782
Peyronie’s disease (PD); length; lengthening; sliding technique; modified sliding technique (MoST); multiple slice technique (MuST); plaque incision (PI) and grafting; subcoronal penile prosthesis (scIPP)
11.  Osteogenic Protein-1 for Long Bone Nonunion 
Executive Summary
To assess the efficacy of osteogenic protein-1 (OP-1) for long bone nonunion.
Clinical Need
Although most fractures heal within a normal period, about 5% to 10% do not heal and are classified as delayed or nonunion fractures. Nonunion and segmental bone loss after fracture, reconstructive surgery, or lesion excision can present complex orthopedic problems, and the multiple surgical procedures often needed are associated with patient morbidity and reduced quality of life.
Many factors contribute to the pathogenesis of a delayed union or nonunion fractures, including deficiencies of calcium, vitamin D, or vitamin C, and side effects of medications such as anticoagulants, steroids, some anti-inflammatory drugs, and radiation. It has been shown that smoking interferes with bone repair in several ways.
Incidence of Nonunion and Delayed Union Cases
An estimated 5% to 10% of fractures do not heal properly and go on to delayed union or nonunion. If this overall estimate of incidence were applied to the Ontario population1, the estimated number of delayed union or nonunion in the province would be between 3,863 and 7,725.
Treatment of Nonunion Cases
The treatment of nonunion cases is a challenge to orthopedic surgeons. However, the basic principle behind treatment is to provide both mechanical and biological support to the nonunion site.
Fracture stabilization and immobilization is frequently used with the other treatment modalities that provide biological support to the fractured bone. Biological support includes materials that could be served as a source of osteogenic cells (osteogenesis), a stimulator of mesenchymal cells (osteoinduction), or a scaffold-like structure (osteoconduction).
The capacity to heal a fracture is a latent potential of the stromal stem cells, which synthesize new bone. This process has been defined as osteogenesis. Activation of the stem cells to initiate osteogenic response and to differentiate into bone-forming osteoblasts is called osteoinduction. These 2 properties accelerate the rate of fracture healing or reactivate the ineffective healing process. Osteoconduction occurs when passive structures facilitate the migration of osteoprogenitor cells, the perivascular tissue, and capillaries into these structures.
Bone Grafts and Bone Graft Substitutes
Bone graft and bone graft substitutes have one or more of the following components:
Undifferentiated stem cells
Growth factors
Structural lattice
Undifferentiated stem cells are unspecialized, multipotential cells that can differentiate into a variety of specialized cells. They can also replicate themselves. The role of stem cells is to maintain and repair the tissue in which they are residing. A single stem cell can generate all cell types of that tissue. Bone marrow is a source of at least 2 kinds of stem cells. Hematopoietic stem cells that form all types of blood cells, and bone marrow stromal stem cells that have osteogenic properties and can generate bone, cartilage, and fibrous tissue.
Bone marrow has been used to stimulate bone formation in bone defects and cases of nonunion fractures. Bone marrow can be aspirated from the iliac crest and injected percutaneously with fluoroscopic guidance into the site of the nonunion fracture. The effectiveness of this technique depends on the number and activity of stem cells in the aspirated bone marrow. It may be possible to increase the proliferation and speed differentiation of stem cells by exposing them to growth factor or by combining them with collagen.
Many growth factors and cytokines induced in response to injury are believed to have a considerable role in the process of repair. Of the many bone growth factors studied, bone morphogenetics (BMPs) have generated the greatest attention because of their osteoinductive potential. The BMPs that have been most widely studied for their ability to induce bone regeneration in humans include BMP-2 and BMP-7 (osteogenic protein). Human osteogenic protein-1 (OP-1) has been cloned and produced with recombinant technology and is free from the risk of infection or allergic reaction.
The structural lattice is osteoconductive; it supports the ingrowth of developing capillaries and perivascular tissues. Three distinct groups of structural lattice have been identified: collagen, calcium sulphate, and calcium phosphate. These materials can be used to replace a lost segment of bone.
Grafts Used for Nonunion
Autologous bone graft is generally considered the gold standard and the best material for grafting because it contains several elements that are critical in promoting bone formation, including osteoprogenitor cells, the matrix, and bone morphogenetic proteins. The osteoconductive property of cancellous autograft is related to the porosity of bone. The highly porous, scaffold-like structure of the graft allows host osteoblasts and host osteoprogenitor cells to migrate easily into the area of the defect and to begin regeneration of bone. Sources of cancellous bone are the iliac crest, the distal femur, the greater trochanter, and the proximal tibia. However, harvesting the autologous bone graft is associated with postoperative pain at the donor site, potential injury to the surrounding arteries, nerves, and tissues, and the risk of infection. Thus the development of synthetic materials with osteoconductive and osteoinductive properties that can eliminate the need for harvesting has become a major goal of orthopedic research.
Allograft is the graft of tissue between individuals who are of the same species but are of a disparate genotype. Allograft has osteoconductive and limited osteoinductive properties. Demineralized bone matrix (DBM) is human cortical and cancellous allograft. These products are prepared by acid extraction of allograft bone, resulting in the loss of most of the mineralized component while collagen and noncollagenous proteins, including growth factors, are retained. Figures 1 to 5 demonstrate the osteogenic, osteoinduction, and osteoconduction properties of autologous bone graft, allograft, OP-1, bone graft substitutes, and bone marrow.
Autologous Bone Graft
Osteogenic Protein-1
Allograft bone and Demineralized Bone Matrix
Bone Graft Substitutes
Autologous Bone Marrow Graft
New Technology Being Reviewed: Osteogenic Protein-1
Health Canada issued a Class IV licence for OP-1 in June 2004 (licence number 36320). The manufacturer of OP-1 is Stryker Biotech (Hapkinton, MA).
The United States Food and Drug Administration (FDA) issued a humanitarian device exemption for the application of the OP-1 implant as an “alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed.” Regulatory agencies in Europe, Australia, and New Zealand have permitted the use of this implant in specific cases, such as in tibial nonunions, or in more general cases, such as in long bone nonunions.
According to the manufacturer, OP-1 is indicated for the treatment of long bone nonunions. It is contraindicated in the patient has a hypersensitivity to the active substance or collagen, and it should not be applied at the site of a resected tumour that is at or near the defect or fracture. Finally, it should not be used in patients who are skeletally immature (< 18 years of age), or if there is no radiological evidence of closure of epiphysis.
Review Strategy
To summarize the safety profile and effectiveness of OP-1 in the treatment of cases of long bone nonunion and bone defects
To compare the effectiveness and cost effectiveness of OP-1 in the treatment of long bone nonunions and bone defects with the alternative technologies, particularly the gold standard autologous bone graft.
Literature Search
International Network of Agencies for Health Technology Assessments (INAHTA), the Cochrane Database of Systematic Reviews and the CCTR (formerly Cochrane Controlled Trials Register) were searched for health technology assessments. MEDLINE, EMBASE, Medline In Process and Other Non-Indexed Citations were searched from January 1, 1996 to January 27, 2004 for studies on OP-1. The search was limited to English-language articles and human studies. The search yielded 47 citations. Three studies met inclusion criteria (2 RCTs and 1 Ontario-based study presented at an international conference.
Summary of Findings
Friedlaender et al. conducted a prospective, randomized, partially blinded clinical trial on the treatment tibial nonunions with OP-1. Tibial nonunions were chosen for this study because of their high frequency, challenging treatment requirements, and substantial morbidity. All of the nonunions were at least 9 months old and had shown no progress toward healing over the previous 3 months. The patients were randomized to receive either treatment with autologous bone grafting or treatment with OP-1 in a type-1 collagen carrier. Both groups received reduction and fixation with an intramedullary rod. Table 1 summarizes the clinical outcomes of this study.
Outcomes in a Randomized Clinical Trial on Tibial Nonunions: Osteogenic Protein-1 versus Autologous Bone Grafting
Clinical success was defined as full weight-bearing, loss of severe pain at the fracture site on weight-bearing, and no further surgical treatment to enhance fracture repair.
The results of this study demonstrated that recombinant OP-1 is associated with substantial clinical and radiographic success for the treatment of tibial nonunions when used with intramedullary rod fixation. No adverse event related to sensitization was reported. Five per cent of the patients in the OP-1 group had circulating antibodies against type 1 collagen. Only 10% of the patients had a low level of anti-OP-1 antibodies, and all effects were transient. Furthermore, the success rate with the OP-1 implant was comparable with those achieved with autograft at 9 and 24 months follow-up. Eighty-two per cent of patients were successful at 24 months follow-up in both groups.
Statistically significant increased blood loss in the group treated with the autograft was observed (P = .049). Patients treated with autograft had longer operation and hospitalization times. All patients in the autograft group had pain at the donor site after surgery, and more than 80% judged their postoperative pain as moderate or severe. At their 6-month visit, 20% of the patients in the autograft group had persistent pain, mild or moderate in nature, at the donor site. This number fell to 13% at 12 months.
All patients in each of the groups had at least 1 adverse event that wasn’t serious, such as fever, nausea and vomiting, leg edema, discomfort, and bruising at the operative site. The incidence of these events was similar in both groups. Serious adverse events were observed in 44% of both groups, none of which were considered related to the OP-1 implant or autograft.
On the basis of this data, the FDA issued a humanitarian device exemption for the application of OP-1 implant as an alternative to autograft in recalcitrant long bone nonunions when the use of autograft is unfeasible and alternative treatments have failed.
Study on Fibular Defects
Geesink et al. investigated the osteogenic activity of OP-1 by assessing its value in bridging fibular defects made at the time of tibial osteotomy for varus or valgus deformity of the knee. This study had 2 phases and included 12 patients in each phase. Each phase included 12 patients (6 in each group). Patients in the first phase received either DBM or were left untreated. Patients in the second phase received either OP-1 on collagen type-1 or collagen type-1 alone.
Radiological and Dual Energy X-ray Absorptiometry (DEXA) evaluation showed that in patients in whom the defect was left untreated, no formation of bone occurred. At 12 months follow-up, new bone formation with bridging occurred in 4 of the 6 patients in DMB group, and 5 of the 6 patients in OP-1 group. One patient in OP-1 group did not show any evidence of new bone formation at any point during the study.
Ontario Pilot Study
A prospective pilot study was conducted in Ontario, Canada to investigate the safety and efficacy of OP-1 for the treatment of recalcitrant long bone nonunions. The study looked at 15 patients with complex, recalcitrant, long bone nonunions whose previous treatment had failed. The investigators concluded that this bone graft substitute appears to be safe and effective in providing sufficient biological stimulation in difficult to treat nonunions. Results of a more complete study on 70 patients are ready for publication. According to the principal investigator, OP-1 was 90% effective in inducing bone formation and bone healing in this sample.
Alternative Technologies
The Medical Advisory Secretariat conducted a literature search from January 1, 2000 to February 28, 2005 to identify studies on nonunions/bone defects that had been treated with alternative technologies. A review of these studies showed that, in addition to the gold standard autologous bone marrow grafting, bone allografts, demineralized bone matrices, bone graft substitutes, and autologous bone marrow have been used for treatment of nonunions and bone defects. These studies were categorized according to the osteoinductive, osteoconductive, and osteogenesis properties of the technologies studied.
A review of these studies showed that bone allografts have been used mostly in various reconstruction procedures to restore the defect after excavating a bone lesion. Two studies investigated the effectiveness of DBM in healing fracture nonunions. Calcium phosphate and calcium sulphate have been used mostly for repair of bone defects.
Several investigators have looked at the use of autologous bone marrow for treatment of long bone nonunions. The results of these studies show that method of percutaneous bone marrow grafting is highly effective in the treatment of long bone nonunions. In a total of 301 fractures across all studies, 268 (89%) healed with a mean healing time of 2.5 to 8 months. This healing time as derived from these case series is less than the timing of the primary end point in Friedlaender’s study (9 months). Table 2 summarizes the results of these studies. Table 2 summarizes the results of these studies.
Studies that used Percutaneous Bone Marrow Grafting for Treatment of Nonunions
Economic Analysis
Based on annual estimated incidence of long-bone nonunion of 3,863 - 7,725, the annual hospitalization costs associated with this condition is between $21.2 and $42.3 million based on a unit cost of $5,477 per hospital separation. When utilized, the device, a single vial of OP-1, is approximately $5,000 and if adopted universally in Ontario, the total device costs would be in the range of $19.3 - $38.6 million annually. The physician fee for harvest, insertion of bone, or OP-1 is $193 and is $193 for autologous bone marrow transplantation. Total annual physician costs are expected to be in the range of from $0.7 million to $1.3 million per year. Expenditures associated with long-bone nonunion are unlikely to increase since incidence of long-bone nonunion is unlikely to change in the future. However, the rate of uptake of OP-1 could have a significant impact on costs if the uptake were large.
The use of OP-1 and autologous bone marrow transplantation may offset pain medication costs compared with those associated with autologous bone harvest given that the former procedures do not involve the pain associated with the bone harvest site. However, given that this pain is normally not permanent, the overall offset is likely to be small. There are likely to be smaller OHIP costs associated with OP-1 than bone-harvest procedures given that only 1, rather than 2, incisions are needed when comparing the former with the latter procedure. This offset could amount to between $0.3 million to $0.7 million annually.
No data on the cost-effectiveness of OP-1 is available.
PMCID: PMC3382627  PMID: 23074475
12.  Dorsal Penile Nerve Block With Ropivacaine-Reduced Postoperative Catheter-Related Bladder Discomfort in Male Patients After Emergence of General Anesthesia 
Medicine  2016;95(15):e3409.
Catheter-related bladder discomfort (CRBD) is a distressing symptom complex after surgery, especially in male patients who have had urinary catheterization under general anesthesia. In this prospective, randomized, controlled trial, we compared dorsal penile nerve block (DPNB) with 0.33% ropivacaine with intravenous tramadol 1.5 mg kg−1 in prevention of CRBD, as well as the incidences of postoperative side effects.
Fifty-eight male patients aged 18 to 50 years, undergoing elective liver surgery and limb surgery with urinary catheterization, were enrolled and divided randomly into 2 groups. In the DPNB group, patients were given dorsal penile nerve block with 15 mL of 0.33% ropivacaine, and in the tramadol intravenous administration (TRAM) group, patients were given 1.5 mg kg−1 tramadol after the completion of surgery before extubation. The primary outcome was the incidence of CRBD, and the secondary outcomes included the severity of CRBD, postoperative side effects, postoperative pain, and the acceptance of urinary catheterization. Patients were evaluated upon arrival to postanesthetic care unit (PACU), at 0.5, 1, 2, 4, and 6 hours after patients’ arrival in the PACU for outcomes.
The incidence of CRBD was significantly lower in the DPNB group than in the TRAM group, either upon arrival to PACU (10.3% vs 37.9%, P = 0.015), or at 0.5 hours (3.4% vs 34.5%, P = 0.003), 1 hours (3.4% vs 37.9%, P = 0.001), 2 hours (6.9% vs 34.5%, P = 0.010), and 4 hours (6.9% vs 27.6%, P = 0.039) after patients’ arrival in PACU. Compared with the TRAM group, the severity of postoperative CRBD upon arrival to PACU (P = 0.011) and at 0.5 hours (P = 0.005), 1 hours (P = 0.002), 2 hours (P = 0.005), 4 hours (P = 0.017), and 6 hours (P = 0.047) after patients’ arrival in PACU were all significantly reduced in the DPNB group. The incidences of postoperative nausea, vomiting, dizziness, and sedation were decreased significantly in the DPNB group compared with the TRAM group (P < 0.05). The acceptance of urinary catheterization was 93.1% (27/29 patients) in the DPNB group and 58.6% (17/29 patients) in the TRAM group, respectively (P < 0.001).
DPNB with ropivacaine has a better effect for CRBD reduction and less side effects than intravenous tramadol administration.
The trial has been registered at (NCT01721031).
PMCID: PMC4839864  PMID: 27082620
13.  Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial 
Trials  2013;14:424.
Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block.
This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay.
Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients.
Trial registration NCT01398982
PMCID: PMC3878890  PMID: 24325953
Autologous abdominal tissue; Breast reconstruction; Donor site; Local pain block; Transversus abdominis plane catheter
14.  AB138. Urinary incontinence could be controlled by inflatable penile prosthesis 
Translational Andrology and Urology  2015;4(Suppl 1):AB138.
Due to the increasing numbers of radical prostatectomy performed for prostate cancer, a substantial and increasing number patients suffer from postoperative urinary incontinence and also erectile failure. Despite the improving surgical techniques, the reported incontinence rates are between 5% and 48%. In patients with dual problems of ED and incontinence, to see whether inflatable penile prosthesis implantation could control the urinary incontinence also. The hypothesis was that progressively inflating penile prosthesis could increase the intraurethral closing pressure to prevent urinary leakiage.
From March 2010 up to May 2015, 25 patients with postradical prostatectomy were referred to our clinic. Seven patients were complained ED only and 18 patients were with persistent urinary incontinence and ED. Inflatable penile prosthesis were implanted in all patients. From one month after operation progressively partial or full inflation were done to control urine leaking. Self-reported results were analysed.
In 13 patients with mild or moderate incontinence group, every patient became dry by partial inflations (30-50%) and every one reported satisfactory outcomes. In 5 severe with total incontinent groups, 4 patients could tolerate incontinence by more than 90% full inflation. Only one patient received 2ndary artificial sphincter implantation.
Urinary incontinence could be controlled by inflating inflatable penile prosthesis by increasing intraurethral closing pressure to prevent leaking. Inflatable penile prosthesis should be considered as an initial surgery, especially in patients with dual problems of ED and incontinence.
PMCID: PMC4708859
Incontinence; inflatable penile prosthesis; prostate cancer; radical prostatectomy
15.  Anesthesia-Based Evaluation of Outcomes of Lower-Extremity Vascular Bypass Procedures 
Annals of vascular surgery  2012;27(2):199-207.
This report examines the effects of regional versus general anesthesia for infrainguinal bypass procedures performed in the treatment of critical limb ischemia (CLI).
Nonemergent infrainguinal bypass procedures for CLI (defined as rest pain or tissue loss) were identified using the 2005 to 2008 American College of Surgeons National Surgical Quality Improvement Program database using International Classification of Disease, ninth edition, and Current Procedure Terminology codes. Patients were classified according to National Surgical Quality Improvement Program data as receiving either general anesthesia or regional anesthesia. The regional anesthesia group included those specified as having regional, spinal, or epidural anesthesia. Demographic, medical, risk factor, operative, and outcomes data were abstracted for the study sample. Individual outcomes were evaluated according to the following morbidity categories: wound, pulmonary, venous thromboembolic, genitourinary, cardiovascular, and operative. Length of stay, total morbidity, and mortality were also evaluated. Associations between anesthesia types and outcomes were evaluated using linear or logistic regression.
A total of 5,462 inpatient hospital visits involving infrainguinal bypasses for CLI were identified. Mean patient age was 69 ± 12 years; 69% were Caucasian; and 39% were female. In all, 4,768 procedures were performed using general anesthesia and 694 with regional anes­thesia. Patients receiving general anesthesia were younger and significantly more likely to have a history of smoking, previous lower-extremity bypass, previous amputation, previous stroke, and a history of a bleeding diathesis including the use of warfarin. Patients receiving regional anesthesia had a higher prevalence of chronic obstructive pulmonary disease.
Tibial-level bypasses were performed in 51% of procedures, whereas 49% of procedures were popliteal-level bypasses. Cases performed using general anesthesia demonstrated a higher rate of resident involvement, need for blood transfusion, and operative time. There was no difference in the rate of popliteal-level and infrapopliteal-level bypasses between groups. Infrapopliteal bypass procedures performed using general anesthesia were more likely to involve prosthetic grafts and composite vein. Mortality occurred in 157 patients (3%). The overall morbidity rate was 37%. Mean and median lengths of stay were 7.5 days (±8.1) and 6.0 days (Q1: 4.0, Q3: 8.0), respectively. Multivariate analyses demonstrated no significant differences by anesthesia type in the incidence of morbidity, mortality, or length of stay.
These results provide no evidence to support the systematic avoidance of general anesthesia for lower-extremity bypass procedures. These data suggest that anesthetic choice should be governed by local expertise and practice patterns.
PMCID: PMC4279240  PMID: 22944010
16.  Penile prostheses 
Penile prosthesis implantation is recognized as a valid option to obtain an artificial erection satisfactory for sexual intercourse in those patients in which a pharmacological approach is contraindicated or ineffective. Penile prostheses are subbject to continuous development and they are achieving ever better mechanical reliability and safety. The devices are divided into two general types: semirigid (malleable and mechanical) and inflatables. The AMS® (American Medical Systems) and Coloplast Ltd® produce the majority of inflatable and semirigid devices.
Malleable and mechanical prostheses have the disadvantage that the penis is always erect although it can be orientated in different ways, while the advantages are ease of use and the need for a simpler surgical procedure compared with inflatable prostheses. Three-component prostheses are more sophisticated than semirigid devices. The advantages of these devices are that the prosthesis feels softer than semirigid or two-piece devices when deflated, with a better cosmetic result, and it ensures a more natural erection than others kinds of prosthesis. The disadvantages are the possibility of malfunction and the need for a more complicated surgical technique. Implantation of a penile prosthesis can be performed in a short surgical time under locoregional anaesthesia, and for this reason hospitalization is usually brief and the patient can be discharged 2 days after the operation if complications are not evident. Patient and partner satisfaction reflect the quality and the effectiveness of this treatment. Even though the results are positive in the vast majority of patients, the possibility of several complications makes penile prosthesis implantation a delicate kind of surgery. Complications can happen when the operation is carried out, in the peri-operative and in the postoperative period, and include infections, erosions of the prosthesis and mechanical failure in case of inflatable prosthesis. Penile prostheses available on the market have improved the success of this kind of surgery, thanks to the introduction of new materials and designs.
PMCID: PMC3126066  PMID: 21789081
penile prosthesis; erectile dysfunction; inflatable prosthesis; semirigid prosthesis
17.  Postoperative Pain and Length of Stay Lowered by Use of Exparel in Immediate, Implant-Based Breast Reconstruction 
Patients undergoing mastectomy and prosthetic breast reconstruction have significant acute postsurgical pain, routinely mandating inpatient hospitalization. Liposomal bupivacaine (LB) (Exparel; Pacira Pharmaceuticals, Inc., Parsippany, N.J.) has been shown to be a safe and effective pain reliever in the immediate postoperative period and may be advantageous for use in mastectomy and breast reconstruction patients.
Retrospective review of 90 immediate implant-based breast reconstruction patient charts was completed. Patients were separated into 3 groups of 30 consecutively treated patients who received 1 of 3 pain treatment modalities: intravenous/oral narcotic pain control (control), bupivacaine pain pump, or LB injection. Length of hospital stay, patient-reported Visual Analog Scale (VAS) pain scores, postoperative patient-controlled analgesia usage, and nausea-related medication use were abstracted and subjected to analysis of variance and multiple linear-regression analysis, as appropriate.
Subjects were well-matched for age (P = 0.24) regardless of pain-control modality. Roughly half (53%) of control and pain pump–treated subjects had bilateral procedures, as opposed to 80% of LB subjects. Mean length of stay for LB subjects was significantly less than control (1.5 days vs 2.00 days; P = 0.016). LB subjects reported significantly lower VAS pain scores at 4, 8, 12, 16, and 24 hours compared with pain pump and control (P < 0.01). There were no adverse events in the LB group.
Use of LB in this group of immediate breast reconstruction patients was associated with decreased patient VAS pain scores in the immediate postoperative period compared with bupivacaine pain pump and intravenous/oral narcotic pain management and reduced inpatient length of stay.
PMCID: PMC4457254  PMID: 26090281
18.  Greek surgical patients’ satisfaction related to perioperative anesthetic services in an academic institute 
Patient satisfaction is an increasingly appreciated measure of outcome for health care procedures. The purpose of this study was to evaluate Greek surgical patients’ satisfaction with perioperative anesthetic services and to determine which factors maximize satisfaction level through all phases of perioperative care.
Adult Greek patients admitted for elective surgery in an academic hospital were included in the study. Three separate questionnaires were constructed: Q1 (patients who underwent general anesthesia alone or combined with epidural) and Q2 (patients who received regional anesthesia alone) covered perioperative anesthetic care; Q3 covered postoperative analgesia services in the ward (patient-controlled analgesia or epidural analgesia) provided by our anesthesiologist-centered analgesia care team. Principal component analysis with varimax rotation was used separately for each questionnaire, and extracted factors were entered into multiple logistic regression with patient satisfaction as the dependent binary variable. Statistical significance level was set at P < 0.05.
Three hundred and forty-five patients were included. Q1 questionnaire (answered by 282 patients) included four dimensions: communication with the anesthesiologist, sense of cold/shivering, pain, and nausea. Q2 questionnaire (answered by 63 patients) included three dimensions: communication with the anesthesiologist, sense of cold/shivering, and nausea/anxiety. Q3 questionnaire (answered by 237 patients) included five dimensions: anesthesiologist intervention upon symptoms, pain, care by the anesthesiologist/physical activity, nausea/vomiting, and anesthesiologist behavior. The communication dimension score in Q1 and Q2, sense of shivering in Q2, and pain management and anesthesiologist behavior dimension scores in Q3 were significantly associated with patient satisfaction. Overall satisfaction rates were high (according to the questionnaire, the observed percentage was in the range of 96.3%–98.6%).
Greek surgical patients reported high satisfaction with perioperative anesthesia care. Interaction between patient and anesthesiologists during all periods of study, absence of shivering in regional anesthesia, and adequate postoperative pain control in the ward were significant predictors of patient satisfaction in the present Greek surgical population.
PMCID: PMC3422116  PMID: 22927750
Greek surgical patients; satisfaction; questionnaire; anesthetic management; postoperative analgesia care team
19.  Predictors of Delayed Postoperative Respiratory Depression Assessed From Naloxone Administration 
Anesthesia and analgesia  2015;121(2):422-429.
To identify patient and procedural characteristics associated with postoperative respiratory depression or sedation that required naloxone intervention.
We identified patients who received naloxone to reverse opioid-induced respiratory depression or sedation within 48 hours after discharge from anesthetic care (transfer from the post anesthesia care unit, or transfer from the operating room to postoperative areas) between July 1, 2008 and June 30, 2010. Patients were matched to two controls based on age, sex, and exact type of procedure performed during the same year. A chart review was performed to identify patient, anesthetic and surgical factors that may be associated with risk for intervention requiring naloxone. In addition, we identified all patients who developed adverse respiratory events [hypoventilation, apnea, oxyhemoglobin desaturation, pain/sedation mismatch] during Phase I anesthesia recovery. We performed conditional logistic regression taking into account the 1:2 matched set case-control study design to assess patient and procedural characteristics associated with naloxone use.
We identified 134 naloxone administrations, 58% within 12 hours of discharge from anesthesia care, with incidence of 1.6 per 1,000 (95% CI 1.3 – 1.9) anesthetics. Presence of obstructive sleep apnea (odds ratio = 2.45, 95%CI 1.27-4.66, P = 0.008), and diagnosis of adverse respiratory event in postanesthesia recovery room (odds ratio = 5.11, 95%CI 2.32-11.27, P < 0.001) were associated with increased risk for requiring naloxone to treat respiratory depression or sedation following discharge from anesthesia care. Following discharge from anesthesia care, patients administered naloxone used a greater median dose of opioids (10 [interquartile range 0, 47.1] vs. 5 [0, 24.8] intravenous morphine equivalents, P = 0.020) and more medications with sedating side effects (N = 41 [31%] vs. 24 [9%], P<0.001).
Obstructive sleep apnea and adverse respiratory events in recovery room are harbingers of increased risk for respiratory depression or sedation requiring naloxone after discharge from anesthesia care. Also, patients administered naloxone received more opioids and other sedating medications after discharge from anesthetic care. Our findings suggest that these patients may benefit from more careful monitoring after being discharged from anesthesia care.
PMCID: PMC4627440  PMID: 25993390
Postoperative complications: respiratory depression; respiratory specific events; obstructive sleep apnea; naloxone; opioids
20.  Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study 
Background:Clinical effects, recovery characteristics, and costs of total intravenous anesthesia with different inhalational anesthetics have been investigated and compared; however, there are no reported clinical studies focusing on the effects of anesthesia with propofol and desflurane in patients undergoing laparoscopic cholecystectomy.
Objective: The aim of this study was to determine the effects of total intravenous anesthesia with propofol and alfentanil compared with those of desflurane and alfentanil on recovery characteristics, postoperative nausea and vomiting (PONV), duration of hospitalization, and gastrointestinal motility.
Methods: Patients classified as American Society of Anesthesiologists physical status I or II undergoing elective laparoscopic cholecystectomy due to benign gallbladder disease were enrolled in the study. Patients were randomly assigned at a 1:1 ratio to receive total intravenous anesthesia with propofol (2–2.5 mg/kg) and alfentanil (20 μg/kg) or desflurane (4%–6%) and alfentanil (20 μg/kg). Perioperative management during premedication, intraoperative analgesia, relaxation, ventilation, and postoperative analgesia were carried out identically in the 2 groups. Extubation time, recovery time, PONV, postoperative antiemetic requirement, time to gastrointestinal motility and flatus, duration of hospitalization, and adverse effects were recorded. Postoperative pain was assessed using a visual analogue scale.
Results: Sixty-eight patients were assessed for inclusion in the study; 5 were excluded because they chose open surgery and 3 did not complete the study because they left the hospital. Sixty patients (33 women, 27 men) completed the study. Recovery time was significantly shorter in the propofol group (n = 30) compared with the desflurane group (n = 30) (8.0 [0.77] vs 9.2 [0.66] min, respectively; P < 0.005). Fifteen patients (50.0%) in the propofol group and 20 patients (66.7%) in the desflurane group experienced nausea during the first 24 hours after surgery. The difference was not considered significant. In the propofol group, significantly fewer patients had vomiting episodes compared with those in the desflurane group (2 [6.7%] vs 16 [53.3%]; P < 0.005). Significantly fewer patients in the propofol group required analgesic medication in the first 24 hours after surgery compared with those in the desflurane group (10 [33.3%] vs 15 [50.0%]; P < 0.005). Patients in the propofol group experienced bowel movements in a significantly shorter period of time compared with patients in the desflurane group (8.30 [1.67] vs 9.76 [1.88] hours; P = 0.02). The mean time to flatus occurred significantly sooner after surgery in the propofol group than in the desflurane group (8.70 [1.79] vs 9.46 [2.09] hours; P = 0.01). The duration of hospitalization after surgery was significantly shorter in the propofol group than in the desflurane group (40.60 [3.49] vs 43.60 [3.56] hours; P = 0.03).
Conclusion: Total intravenous anesthesia with propofol and alfentanil was associated with a significantly reduced rate of PONV and analgesic consumption, shortened recovery time and duration of hospitalization, accelerated onset of bowel movements, and increased patient satisfaction compared with desflurane and alfentanil in these patients undergoing laparoscopic surgery who completed the study.
PMCID: PMC3967343  PMID: 24683221
total intravenous anesthesia; propofol; desflurane; alfentanil; laparoscopic cholecystectomy
21.  Urinary Incontinence Could Be Controlled by an Inflatable Penile Prosthesis 
Due to the increasing numbers of radical prostatectomies (RP) performed for prostate cancer, a substantial and increasing number of patients suffer from postoperative urinary incontinence and erectile dysfunction (ED). The objective of our study was to see whether an inflatable penile prosthesis implantation could control urinary incontinence for patients with the dual problems of ED and incontinence.
Materials and Methods
From March 2010 through May 2015, 25 post-RP patients were referred to our clinic with ED or incontinence. The degree of incontinence was classified according to the International Consultation on Incontinence Questionnaire-Short Form. Inflatable penile prostheses were implanted in all 25 patients.
For one month after implantation, partial or full inflation was performed progressively to control urine leakage. Of 18 patients, 13 patients were categorized with mild or moderate stress incontinence. All 13 patients obtained control of incontinence with partial inflation (30% to 60%) and all reported satisfactory outcomes. Five out of the 18 patients were categorized with severe total incontinence. Three of the 5 patients could tolerate incontinence with full inflation on and off. Thirteen patients out of the total of 18 (72.2%) had their incontinence controlled by an inflating penile prosthesis.
An inflatable penile prosthesis is highly recommended as an initial procedure, especially in patients with the dual problems of ED and incontinence.
PMCID: PMC4853768  PMID: 27169127
Erectile dysfunction; Penile prosthesis; Prostatectomy; Urinary incontinence
22.  Suprapubic Cystostomy for the Management of Urethral Injuries During Penile Prosthesis Implantation 
Sexual Medicine  2014;2(4):178-181.
Urethral injury is an uncommon surgical complication of penile prosthesis (PP) surgery. Conventional dogma requires abortion of the procedure if the adjacent corporal body is involved or delayed implantation to avert device infection associated with urinary extravasation. Besides the setback of the aborted surgery, this management approach also presents the possible difficulty of encountering corporal fibrosis at the time of reoperation.
We report an approach using primary urethral repair and temporary suprapubic cystostomy for the management of incidental urethral injuries in a cohort of patients allowing for successful completion of unaborted PP implantation.
Materials and Methods
We performed a retrospective analysis of all patients receiving PPs from 1990 to 2014 in which incidental urethral injuries were repaired and PP implantation was completed with suprapubic cystostomy (suprapubic tube [SPT] insertion). After allowing for urethral healing and urinary diversion via SPT for 4–8 weeks, the PP was activated.
Main Outcome Measures
Successful management was determined by the absence of perioperative complications within 6 months of implantation.
We identified four cases, all receiving inflatable PPs, managed with temporary suprapubic cystostomy. These patients sustained urethral injuries during corporal dissection (one patient), corporal dilation (one patient), and penile straightening (two patients). All patients were managed safely and successfully.
Primary urethral repair followed by temporary suprapubic cystostomy offers a surgical approach to complete PP implantation successfully in patients who sustain urethral injury complications, particularly for complex PP surgeries. Anele UA, Le BV, and Burnett AL. Suprapubic cystostomy for the management of urethral injuries during penile prosthesis implantation.
PMCID: PMC4272249  PMID: 25548649
Penile Reconstruction; Penile Fibrosis; Corporal Dilation; Erectile Dysfunction; SPT
23.  Strategies for maintaining penile size following penile implant 
Loss of penile size is a common complaint that can negatively affect patient satisfaction rates following successful penile prosthetic implant surgery.
The aim of this review is to describe the various strategies that have been used to maintain penile length or girth after the insertion of a penile prosthetic implant.
An extensive systematic literature review was performed, based on a search of the PUBMED database for articles published between 2002 to 2012. The following key words were used: penile prosthesis, implant, penile length, size, penis, enhancement, enlargement, phalloplasty, girth, lengthening, and augmentation. Only English-language articles that were related to penile prosthetic surgery and penile size were sought.
Based on the results of our search, strategies were classified into 3 groups based on the timepoint in relation to the primary penile prosthetic insertion surgery, which included pre-insertion, intraoperative and post-insertion.
Strategies to preserve and potentially increase penile size are of great importance to all implanters. Besides traction therapies and surgeries to enhance perceived penile size, refinements in the surgical approach are simple ways to optimize penile length. A direct comparison of treatment outcomes evaluating the various approaches is not currently possible, owing to divergent study techniques. The implanting surgeon can best serve his patient by adopting a combination of different strategies that are individualized and specific to the patient’s needs.
PMCID: PMC4708606  PMID: 26816726
Penile prosthesis; implant; penis size; length; enhancement
24.  Long-term survival and patient satisfaction with inflatable penile prosthesis for the treatment of erectile dysfunction 
Korean Journal of Urology  2015;56(6):461-465.
We investigated the long-term survival and patient satisfaction with an inflatable penile prosthesis as a treatment for refractory erectile dysfunction (ED).
Materials and Methods
Between July 1997 and September 2014, a total of 74 patients underwent implantation of an inflatable penile prosthesis. The present mechanical status of the prosthesis was ascertained by telephone interview and review of medical records, and related clinical factors were analyzed by using Cox proportional hazard regression model. To investigate current status and satisfaction with the devices, novel questionnaires consisting of eight items were administered.
The mean (±standard deviation) age and follow-up period were 57.0±12.2 years and 105.5±64.0 months, respectively. Sixteen patients (21.6%) experienced a mechanical failure and 4 patients (5.4%) experienced a nonmechanical failure at a median follow-up of 98.0 months. Mechanical and overall survival rates of the inflatable penile prosthesis at 5, 10, and 15 years were 93.3%, 76.5%, and 64.8% and 89.1%, 71.4%, and 60.5%, respectively, without a statistically significant correlation with host factors including age, cause of ED, and presence of obesity, hypertension, and diabetes mellitus. Overall, 53 patients (71.6%) completed the questionnaires. The overall patient satisfaction rate was 86.8%, and 83.0% of the patients replied that they intended to repeat the same procedure. Among the 8 items asked, satisfaction with the rigidity of the device received the highest score (90.6%). In contrast, only 60.4% of subjects experienced orgasm.
The results of our study suggest that excellent long-term reliability and high patient satisfaction rates make the implantation of an inflatable penile prosthesis a recommendable surgical treatment for refractory ED.
PMCID: PMC4462637  PMID: 26078844
Erectile dysfunction; Patient satisfaction; Penile prosthesis; Survival
25.  Penile block for paediatric urological surgery: A comparative evaluation with general anaesthesia 
Peri-operative pain relief in children can be provided by conventional general anaesthesia or by regional nerve blocks. The present study was carried out to evaluate and compare the effectiveness of penile block for penile surgery with the standard technique of general anaesthesia (GA) of short duration of less than two hours, and also to evaluate the postoperative pain relief obtained by penile block.
Materials and Methods:
The study was carried out in the department of Anaesthesiology and Intensive care of our hospital, on 60 children in the age group of 1-10 years, belonging to American Society of Anesthesiologists (ASA) grades I and II, and divided randomly into two groups: Group B and group G, comprising of 30 patients each. Group B children received a penile block whereas group G children underwent a standard general anaesthetic procedure. Baseline, intra-operative and post-operative heart rate (HR), electrocardiogram (ECG), non-invasive blood pressure (NIBP) (systolic and diastolic) and pulse oximeter oxygen saturation (SpO2) were recorded at regular intervals. The duration of post-operative pain relief, time to rescue analgesia and time to first feed were also evaluated and recorded. Statistical analysis was carried out using statistical package for social sciences (SPSS) 11 version for windows and employing analysis of variance (ANOVA), unpaired student t test, Chi-square test and Mann Whitney U test for various parameters. Value of P<0.05 was considered as significant and P<0.0001 as highly significant.
The demographic characteristics were comparable in both the groups. Heart rate, systolic blood pressure, diastolic blood pressure and pulse oximetry showed remarkable differences at various time intervals during intra-operative and post-operative period, which were statistically significant on comparison (P<0.05 and P<0.0001). Post-operative pain relief, time to first rescue analgesia and time to first feed also showed statistically significant differences.
Penile block is very effective when used along with light sedation for distal penile surgeries of less than 2 hours duration as compared to standard GA as reflected by more stable haemodynamics in peri-operative period, excellent pain relief extending up to 6-8 hrs postoperatively and absence of any significant complications or side effects.
PMCID: PMC3263211  PMID: 22279309
Bupivacaine; general anaesthesia; penile block; penile surgery

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