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1.  Transobturator tapes are preferable over transvaginal tapes for the management of female stress urinary incontinence: Against 
Midurethral placement of tension-free vaginal tapes with a transvaginal route for stress urinary incontinence achieves higher and better long-term success rates than the transobturator route. Bladder perforations are reported more in transvaginal tape (TVT) but incidences of vaginal erosions, extrusion, and groin pain are exceedingly more in TOT groups. There is no clear evidence that transobturator tape (TOT) is associated with less post-operative voiding problems than TVT. Major complications such as bowel injuries and significant vascular injuries with TVT are rare. TVT has been found to be superior to TOT and preferable in technically demanding conditions such as prior anti-incontinence operation failures, obese women, and very elevated and scarred lateral cul-de sac. TVT is always preferred in severe grades of stress urinary incontinence and with patients of intrinsic sphincter deficiency (ISD) with little or no urethral mobility.
doi:10.4103/0970-1591.57903
PMCID: PMC2808672  PMID: 19955693
Stress urinary incontinence; transvaginal tape; transobturator tapes
2.  Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up 
Background:
The tension-free vaginal tape (TVT) procedure is based on the integral theory that the midurethra has an important role in the continence mechanism. Transobturator vaginal tape (TOT) is the same in concept as TVT but it differs from TVT in that, rather than passing through the retropubic space, sling materials are drawn through the obturator foramina. We prospectively compared TVT with TOT with respect to operation-related morbidity and surgical outcomes at a minimum follow up of 12 months.
Materials and Methods:
A total of 36 women with stress urinary incontinence (SUI) were alternatively assigned to the TVT group (18) or the TOT group. Preoperative evaluation included urodynamic study and I-QOL questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality-of-life questionnaire, long-term complications, and uroflowmetry were evaluated in both groups.
Results:
The patient characteristics in both the TVT and TOT group were similar. Mean operating time was significantly shorter in the TOT group likened to the TVT group.
Conclusions:
Both the TVT and TOT procedures are minimally invasive and similar in operation-related morbidity. TOT appears to be as effective as TVT, and safer than TVT for the surgical treatment of SUI in women at 12 months follow-up.
doi:10.4103/0970-1591.56183
PMCID: PMC2779952  PMID: 19881123
Quality of life; stress; transobturator; urinary incontinence; vaginal tape
3.  Comparison of Efficacy and Satisfaction between the TVT-SECUR® and MONARC® Procedures for the Treatment of Female Stress Urinary Incontinence 
Korean Journal of Urology  2010;51(11):767-771.
Purpose
The tension-free vaginal tape SECUR® (TVT-S) is a new, minimally invasive sling procedure for treating female stress urinary incontinence (SUI). However, results of comparisons of the TVT-S with the transobturator tape (TOT) sling are lacking. Therefore, we investigated outcome and satisfaction of the TVT-S procedure compared with the TOT procedure.
Materials and Methods
We included 64 patients with SUI who underwent the TVT-S (n=31) or TOT (MONARC®, n=33) procedure and were followed up for more than 1 year. The preoperative evaluation included history taking, pelvic examination, consecutive 3-day voiding diary, and urodynamic study including Valsalva leak point pressure. Postoperatively, continence status and subjective patient satisfaction were evaluated. Cure was defined as the absence of any episodes of involuntary urine leakage during stressful activities and a stress cough test.
Results
The TVT-S group (71.0%) showed a slightly lower cure rate than did the MONARC group (84.8%); however, there was no significant difference between the 2 groups (p=0.179). Nine of the patients who underwent the TVT-S showed incontinence postoperatively. Among them, the H approach was used in 7 patients and the U approach was done in 2 patients. Following TVT-S and MONARC, the patients' reported satisfaction was 80.6% and 78.8%, respectively. Patient satisfaction did not differ significantly between the two groups (p=0.854).
Conclusions
Our results showed that the TVT-S and MONARC procedures may be comparable in terms of cure rate and patient satisfaction after more than 1 year of follow-up.
doi:10.4111/kju.2010.51.11.767
PMCID: PMC2991574  PMID: 21165197
Minimally invasive surgical procedures; Treatment outcome; Urinary stress incontinence
4.  Efficacy and Safety of the TVT-SECUR® and Impact on Quality of Life in Women with Stress Urinary Incontinence: A 2-Year Follow-Up 
Korean Journal of Urology  2011;52(5):335-339.
Purpose
As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress urinary incontinence (SUI) during 2 years.
Materials and Methods
We evaluated 51 patients with clinical and urodynamic diagnoses of SUI who underwent the TVT-S procedure from March 2008 to February 2009. Preoperative evaluation included a history, cough stress test with full bladder, urodynamic study, and incontinence quality of life (I-QoL) questionnaire. Following the postoperative period, urinary incontinence status was examined through a physical examination and the I-QoL questionnaire was completed in an outpatient setting or by telephone.
Results
Data from 2 years of follow-up were available for 46 of 51 patients. The cure rate was 80.4% at 1 month after TVT-S and 76.0% at 2 years after TVT-S. The cure or improvement rate was 93.5% at 1 month after TVT-S and 86.8% at 2 years after TVT-S. The mean total I-QoL score increased by 42 points at 1 month after TVT-S (p<0.026) and by 32 points at 2 years after TVT-S (p<0.013). Most patients reported significant improvements in quality of life. At the 2-year follow-up, there were no significant complications related to TVT-S.
Conclusions
The results of this study suggest that TVT-S is an efficient and safe procedure for the improvement of both the quality of life of the patients and the SUI itself.
doi:10.4111/kju.2011.52.5.335
PMCID: PMC3106166  PMID: 21687393
Minimally invasive surgical procedures; Treatment outcome; Urinary stress incontinence
5.  Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence 
Purpose
We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI).
Methods
Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months.
Results
In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups.
Conclusions
Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O.
doi:10.5213/inj.2013.17.3.145
PMCID: PMC3797895  PMID: 24143294
Overactive urinary bladder; Stress urinary incontinence
6.  Complications Following Outside-in and Inside-out Transobturator-Tape Procedures with Concomitant Gynecologic Operations 
Chonnam Medical Journal  2011;47(3):165-169.
This study was undertaken to compare the complications of outside-in transobturator tape procedures (TOT) and inside-out transobturator tape procedures (TVT-O) with concomitant gynecologic surgery for the treatment of female stress urinary incontinence (SUI). A retrospective review of 206 consecutive patients who underwent either TOT or TVT-O with concomitant gynecologic operations between March 2008 and February 2011 was conducted. The incidence of perioperative complications was compared. For statistical analysis, chi-squared tests were used. There were no reports of intraoperative complications such as vaginal injury or bladder perforation. Postoperative complications were noted in 23 procedures (11.2%). These included 6 cases of urinary retention (2.9%), 2 cases of vulva hematoma (1.0%), 7 cases of urinary tract infection (3.4%), 4 cases of de novo urgency (2.9%), and 4 cases of vaginal erosion (2.9%). There were no significant differences in complication rates between the two groups. Our results suggest that inside-out and outside-in procedures are simple and safe techniques that may have a low rate of complications when used with a concomitant gynecologic operation.
doi:10.4068/cmj.2011.47.3.165
PMCID: PMC3252505  PMID: 22247917
Complications; Urinary stress incontinence; Gynecologic surgical procedures
7.  A severe complication of mid-urethral tapes solved by laparoscopic tape removal and ureterocutaneostomy 
Canadian Urological Association Journal  2013;7(9-10):E598-E600.
Mid-urethral tapes are largely used to manage stress urinary incontinence (SUI). In certain cases, however, this procedure results in bothersome complications that lead to complete resection. We present the case of an 85-year-old woman who presented with ongoing suprapubic pain, hematuria, vaginal bleeding and recurrent urinary tract infections. The patient had undergone a tension-free vaginal tape (TVT) procedure in 1999 and a transobturator tape (TOT) placement in 2003 for SUI. Investigations revealed a urethral stone, erosion of both TOT and TVT and an urethra-vaginal fistula. Under local anesthesia the urethral stone was removed endoscopically and the TOT removed via a vaginal approach. Due to her comorbidity, she underwent a laparoscopic intraperitoneal removal of the TVT and a definitive ureterocutaneostomy to relieve her pain, inflammation and incontinence. This is the first ever presented case of erosion of mid-urethral tapes and incontinence treated with a laparoscopic resection of the tape and ureterocutaneostomy as definitive urinary diversion.
doi:10.5489/cuaj.393
PMCID: PMC3776037  PMID: 24069104
8.  Vaginal Mucosal Flap as a Sling Preservation for the Treatment of Vaginal Exposure of Mesh 
Korean Journal of Urology  2010;51(6):416-419.
Purpose
Tension-free vaginal tape (TVT) procedures are used for the treatment of stress urinary incontinence in women. The procedures with synthetic materials can have a risk of vaginal erosion. We experienced transobturator suburethral sling (TOT) tape-induced vaginal erosion and report the efficacy of a vaginal mucosal covering technique.
Materials and Methods
A total of 560 female patients diagnosed with stress urinary incontinence underwent TOT procedures at our hospital between January 2005 and August 2009. All patients succeeded in follow-ups, among which 8 patients (mean age: 50.5 years) presented with vaginal exposure of the mesh. A vaginal mucosal covering technique was performed under local anesthesia after administration of antibiotics and vaginal wound dressings for 3-4 days.
Results
Seven of the 8 patients complained of persistent vaginal discharge postoperatively. Two of the 8 patients complained of dyspareunia of their male partners. The one remaining patient was otherwise asymptomatic, but mesh erosion was discovered at the routine follow-up visit. Six of the 8 patients showed complete mucosal covering of the mesh after the operation (mean follow-up period: 16 moths). Vaginal mucosal erosion recurred in 2 patients, and the mesh was then partially removed. One patient had recurrent stress urinary incontinence.
Conclusions
Vaginal mucosal covering as a sling preservation with continued patient continence may be a feasible and effective option for the treatment of vaginal exposure of mesh after TOT tape procedures.
doi:10.4111/kju.2010.51.6.416
PMCID: PMC2890059  PMID: 20577609
Complications; Suburethral slings; Surgical mesh
9.  Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial 
BMC Women's Health  2011;11:34.
Background
We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial.
Methods/Design
All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature.
Discussion
This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is less effective, will have a significant impact on individual quality of life, and societal and health care costs.
Trial registration
ClinicalTrials.gov NCT00234754. Registered October 2005.
doi:10.1186/1472-6874-11-34
PMCID: PMC3171308  PMID: 21781314
Urinary incontinence; stress/surgery; suburethral slings; female; treatment outcome; cost-effectiveness; 5 year follow-u
10.  Three-year Outcomes of the Innovative Replacement of Incontinence Surgery Procedure for Treatment of Female Stress Urinary Incontinence: Comparison with Tension-free Vaginal Tape Procedure 
Journal of Korean Medical Science  2007;22(3):497-501.
Innovative replacement of incontinence surgery (IRIS) is a polypropylene tape that is placed beneath the midurethra to restore urinary continence. We evaluated the long-term efficacy and safety of the IRIS procedure and compared it with tension-free vaginal tape (TVT) for the treatment of female stress urinary incontinence. We included all 66 consecutive women who underwent IRIS (n=34) or TVT (n=32) between February 2002 and April 2003 and followed them up for at least 3 yr postoperatively. The 3-yr success rate was 94.1% for the IRIS and 93.8% for the TVT, and the satisfaction rates were 91.2% and 90.6%, respectively. Intraoperative complications for the IRIS group included 3 cases of bladder perforation, and there were 3 cases of bladder perforation in the TVT group. The postoperative complications for the IRIS group included 2 patients with de novo urgency and one patient with mesh erosion. Three patients with TVT developed de novo urgency. One case of each group showed temporary voiding difficulty. On the basis of our results, the IRIS may be an effective and safe procedure as compared to TVT, with a high success rate and a low complication rate.
doi:10.3346/jkms.2007.22.3.497
PMCID: PMC2693644  PMID: 17596660
Urinary Incontinence, Stress; Urologic Surgical Procedures
11.  Outcome of Treatment of Anterior Vaginal Wall Prolapse and Stress Urinary Incontinence with Transobturator Tension-Free Vaginal Mesh (Prolift) and Concomitant Tension-Free Vaginal Tape-Obturator 
Advances in Urology  2008;2009:341268.
Objective. It is to assess the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift) and concomitant tension-free vaginal tape-obturator (TVT-O) system as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI). Patients and Methods. Between December 2006 and July 2007, 20 patients with anterior genital prolapse and voiding dysfunction were treated with the transobturator tension-free vaginal mesh (Prolift) and concomitant tension-free vaginal tape-obturator (TVT-O). Sixteen patients had stress urinary incontinence and 4 patients were considered at risk for development of de novo stress incontinence after the prolapse is repaired. All patients underwent a complete urodynamic assessment. All the patients underwent pelvic examination 4–6 weeks after the operation, and anatomical and functional outcomes were recorded. Results. Twenty cystocoeles were repaired: 6 grade II, 12 grade III, and 2 grade IV. There were no vessel or bladder injuries. Eighteen patients had optimal anatomic results and 2 patients had persistent asymptomatic stage I prolapse. Conclusion. These preliminary results suggest that Prolift system offers a safe and effective treatment for female anterior vaginal wall prolapse. However, a long-term followup is necessary in order to support the good result maintenance.
doi:10.1155/2009/341268
PMCID: PMC2610388  PMID: 19125198
12.  Comparison of TOA and TOT for Treating Female Stress Urinary Incontinence: Short-Term Outcomes 
Korean Journal of Urology  2010;51(8):544-549.
Purpose
The transobturator adjustable tape (TOA) sling operation is a new procedure that allows for the adjustment of tension after surgical intervention, thus permitting correction of postoperative incontinence or obstruction. The aim of this study was to compare the efficacy and safety of TOA with that of the transobturator tape (TOT) procedure.
Materials and Methods
Between 2008 and 2009, women with stress urinary incontinence (SUI) underwent TOT (n=63) or TOA (n=40). The preoperative evaluation included history taking, physical examination, voiding diary, stress and 1-hour pad tests, and a comprehensive urodynamic examination. Postoperative evaluation was performed at the 1-week and 3-month postoperative follow-up visits.
Results
The overall cure rate was 90.0% for the TOA group and 85.7% for the TOT group. The rate of satisfaction was higher in the TOA group than in the TOT group (95.0% vs. 85.6%). Four patients in the TOA group needed reduced tension as the result of urinary obstruction. The tension of the mesh was tightened in 1 patient because of a certain degree of continuing incontinence. The residual urine volume was significantly lower in the TOA group than in the TOT group (7.8 ml vs. 43 ml, p=0.01).
Conclusions
TOA allowed postoperative readjustment for a number of days after surgical intervention, which allowed for good short-term treatment outcomes. These data suggest that better subjective and objective results and residual urine volume can be obtained in the TOA group than those achieved with the traditional non-adjustable mesh and without significant postoperative complications.
doi:10.4111/kju.2010.51.8.544
PMCID: PMC2924558  PMID: 20733960
Stress urinary incontinence; Suburethral slings; Treatment outcome
13.  TVT-O versus Monarc after a 2–4-year follow-up: a prospective comparative study 
Introduction and hypothesis
The aim of this study was to compare outcome and quality of life of tension-free vaginal tape “inside-out” (TVT-O) and Monarc transobturator tapes after 2–4 years.
Methods
The method used was a prospective comparative study. Participants (n = 191) were assigned to either a TVT-O (n = 93) or a Monarc (n = 98) procedure. Cure of stress urinary incontinence (SUI) was defined as the statement of the woman of not experiencing any loss of urine upon physical exercise.
Results
Cure rates after 2–4 years were 72% for TVT-O and 65% for Monarc, while improvement was observed in, respectively, 12% and 21% (p = 0.3). There was a statistically significant improvement in quality of life but no differences were found between both procedures.
Conclusions
After a 2–4-year follow-up period, both procedures were equally safe and effective in curing SUI.
doi:10.1007/s00192-009-0943-5
PMCID: PMC2762523  PMID: 19597718
Monarc; Stress urinary incontinence; Transobturator tape; TVT-O
14.  Cost effectiveness of radiofrequency microremodeling for stress urinary incontinence 
Introduction and hypothesis
Stress urinary incontinence (SUI) is a common and growing problem among adult women and affects individuals and society through decreased quality of life (QoL), decreased work productivity, and increased health care costs. A new, nonsurgical treatment option has become available for women who have failed conservative therapy, but its cost effectiveness has not been evaluated. This study examined the cost effectiveness of transurethral radiofrequency microremodeling of the female bladder neck and proximal urethra compared with synthetic transobturator tape (TOT), retropubic transvaginal tape (TVT) sling, and Burch colposuspension surgeries for treating SUI.
Methods
A Markov model was used to compare the cost effectiveness of five strategies for treating SUI for patients who had previously failed conservative therapy. The strategies were designed to compare the value of starting with a less invasive treatment. The cost-effectiveness analysis was conducted from the health care system perspective. Efficacy and adverse event rates were obtained from the literature; reimbursement costs were based on Medicare fee schedule. The model cycle was 3 months, with a 3-year time horizon. Single-variable sensitivity analyses were conducted to assess stability of base-case results.
Results
Two of the five strategies employed the use of transurethral radiofrequency microremodeling and achieved 17–30 % lower mean costs relative to their comparative sling or Burch strategies.
Conclusions
Superior safety and cost effectiveness are recognized when patients are offered a sequential approach to SUI management that employs transurethral radiofrequency microremodeling before invasive surgical procedures. This sequential approach is consistent with treatment strategies for other conditions and offers a solution for women with SUI who want to avoid the inherent risks and costs of invasive continence surgery.
doi:10.1007/s00192-013-2230-8
PMCID: PMC3964292  PMID: 24108392
Burch; Cost effectiveness; Radiofrequency; Sling; Stress urinary incontinence; Transurethral
15.  One-Year Surgical Outcomes and Quality of Life after Minimally Invasive Sling Procedures for the Treatment of Female Stress Urinary Incontinence: TVT SECUR® vs. CureMesh® 
Korean Journal of Urology  2010;51(5):337-343.
Purpose
We compared the efficacy and safety of two minimally invasive sling procedures used to treat female stress urinary incontinence (SUI), tension-free vaginal tape (TVT) SECUR® and CureMesh®, and assessed the 1-year surgical outcomes.
Materials and Methods
Sixty women with SUI were assigned to undergo either the TVT SECUR (n=38) or CureMesh (n=22) procedures between April 2007 and June 2008. Patients were monitored via outpatient visits at 1 month, 3 months, and 1 year after surgery. The efficacy of these procedures was evaluated by the cough test or by a urodynamic study. At these postoperative visits, the patients also completed several questionnaires, including incontinence quality of life, patient's perception of urgency severity, the scored form of the Bristol Female Lower Urinary Tract Symptoms, visual analog scale, and questions about perceived benefit, satisfaction, and willingness to undergo the same operation again. The objective cure rate was defined as no leakage during the cough test with a full bladder. The subjective cure rate was evaluated by self-assessment of goal achievement performed 1 year postoperatively.
Results
The two groups were similar in preoperative characteristics and urodynamic parameters. The objective cure rates were similar between TVT SECUR and CureMesh (68.4% vs. 77.3%). All respondents reported improvement after surgery. There were no intra-operative complications.
Conclusions
Our results showed that the TVT SECUR and CureMesh procedures are both safe and simple to perform and have no significant differences in efficacy. Comparative studies with long-term follow-up are warranted to determine the true efficacy of these procedures.
doi:10.4111/kju.2010.51.5.337
PMCID: PMC2873888  PMID: 20495697
Minimally invasive surgical procedures; Stress urinary incontinence; Treatment outcome
16.  Tape functionality: position, change in shape, and outcome after TVT procedure—mid-term results 
Introduction and hypothesis
This study evaluates the relevance of the tape position and change in shape (tape functionality) under in vivo conditions for mid-term outcome.
Methods
Changes in the sonographic tension-free vaginal tape (TVT) position relative to the percentage urethral length and the tape–urethra distance were determined after 6 and 48 months in 41 women with stress urinary incontinence.
Results
At 48 months, 76% (31/41) of women were cured, 17% (7/41) were improved, and 7% (3/41) were failures. Disturbed bladder voiding was present in 12% (5/41), de novo urge incontinence in 7% (3/41). The median TVT position was at 63% of urethral length. Median tape–urethra distance was 2.7 mm, ranging from 2.9 mm in continent patients without complications to 1.1 mm in those with obstructive complications. Patients with postoperative urine loss had a median distance of 3.9 mm. The tape was stretched at rest and C-shaped during straining in 15 of 41 women (37%) at 48 months (all continent). Patients with this tape functionality at 6 months were also cured at 48 months in 86% of cases (19/22), and only 14% (3/22) showed recurrent incontinence.
Conclusions
Mid-term data suggest an optimal outcome if the tape is positioned at least 2 mm from the urethra at the junction of the middle and distal thirds. Patients with optimal tape functionality at 6 months are likely to show mid-term therapeutic success.
doi:10.1007/s00192-010-1119-z
PMCID: PMC2876268  PMID: 20204326
Introital ultrasound; Mid-term outcome; Stress urinary incontinence; Tape position; Tape tension→tape functionality; Tension-free vaginal tape (TVT)
17.  Midurethral Slings for Women with Stress Urinary Incontinence 
Executive Summary
Objective
The objective of the current review was to evaluate the safety, efficacy, and cost-effectiveness of midurethral slings compared with traditional surgery.
Background
This assessment was undertaken in order to update and expand upon the health technology & policy assessment of tension-free vaginal tape (TVT, Gynecare Worldwide, a division of Ethicon Inc, a Johnson & Johnson company, Somerville, New Jersey) sling procedure for stress urinary incontinence published by the Medical Advisory Secretariat in February 2004. Since the publication of the 2004 assessment, a number of TVT-like sling alternatives have become available which employ the same basic principles as TVT slings: minimally invasive, midurethral placement, self-fixing, and tension-free. This update will evaluate the efficacy and safety of midurethral slings.
Clinical Need
Normal continence is controlled by the nervous system and involves co-ordination between bladder, urethra, urethral sphincter, and pelvic floor. Incontinence occurs when the relationship among the above components is compromised, either due to physical damage or nerve dysfunction. (1) Stress urinary incontinence is the most common form of urinary incontinence in women. It is characterized by the “complaint of involuntary leakage on effort or exertion, or on sneezing or coughing” when there is increased abdominal pressure without detrusor (bladder wall) contraction. (2) There are 2 factors which define stress urinary incontinence: a weakening in the support of the proximal urethra, causing urethral hyper-mobility and deficiency in the sphincter, causing urethral leakage. Both factors are thought to coexist. (1) Accurate tests are not available to distinguish these 2 types of stress urinary incontinence.
Urinary incontinence is estimated to affect about 250,000 Canadian women and 8 million American women aged 65 and over. (3;4) The prevalence of stress urinary incontinence is very difficult to measure because women with stress urinary incontinence may not tell their health practitioner about their symptoms due to embarrassment associated with stress urinary incontinence. A cross-sectional postal survey of 15,904 adults aged 40 and over who were registered with a local GP in Leicestershire, United Kingdom, revealed that 18% to 34% of respondents had symptoms of SUI. (5) Just over 9% reported symptoms “sometimes,” while almost 3% reported symptoms “most of the time.” Stress urinary incontinence was most common for women in their 50s. A more recent study suggests that 24% of women aged 18 to 44 years and 37% of women aged 45 and over have symptoms of stress urinary incontinence. (6)
Stress urinary incontinence has been associated with a broad range of psychosocial stress and disablement, such as difficulties with activities of daily living, avoidance of social activities, fear of unpleasant odour, and embarrassment. (7) Economic burden may include the cost of pads, drugs, and devices, and the inability to participate in the work force in severe cases.
Midurethral Slings
Suburethral slings differ according to several criteria including placement, approach, method of fixation, and sling material. This review will evaluate slings which fulfill all of the following criteria:
Midurethral placement (as opposed to bladder neck placement)
Self-fixing (no sutures, bone anchors, etc.)
Minimally invasive (using local, epidural, or general anesthesia)
“Tension-free” placement
The different types of midurethral slings available vary according to 3 main parameters:
Implant material, i.e., monofilament, multifilament, elastic, non-elastic, smooth, serrated, etc.,
Delivery instruments, i.e., needles, curved trocars, disposable, reusable, etc.,
Surgical approach
As any one, or any combination of these parameters may vary across the different sling brands, it is difficult to ascribe observed differences in efficacy and safety across slings to any one factor.
Review Strategy
The literature published between January 2000 and February 2006 was searched in the following databases: OVID Medline, In Process and Other Non-Indexed Citations, Embase, Cochrane Database of Systematic Reviews and CENTRAL, INAHTA. The database search was supplemented with a search of relevant Web sites, and a review of the bibliographies of selected papers. The search strategy can be viewed in Appendix 1.
Inclusion Criteria
General population with SUI
Randomized controlled studies, health technology assessments, guidelines
Female subjects
Midurethral, self-fixing, and minimally invasive slings/tapes
English language
The search strategy yielded 391 original citations. Studies were excluded for a variety of reasons, such as using traditional, suburethral slings as opposed to midurethral slings, not including patients with stress urinary incontinence, including males in the study, case reports, and not reporting the outcomes of interest.
There were 13 randomized controlled trials identified that compared midurethral slings to other midurethral slings or traditional surgery. (8-20) (Table 1) Three of the randomized controlled trials (15;17;20) have had subsequent updated articles of longer term results. (21-23) The results of the randomized controlled trials have been stratified into 2 groups: TVT versus colposuspension and comparisons of midurethral slings. No randomized controlled trials were identified that compared a midurethral sling other than TVT to colposuspension.
Summary of Findings
Effectiveness
At this time, there does not appear to be one procedure that is more effective than another at curing stress urinary incontinence. TVT appears to have similar cure rates to open colposuspension; and the various midurethral sling types seem to have similar cure rates.
Procedure Time and Length of Hospital Stay
The procedure time and the length of hospital stay for TVT are significantly shorter than the procedure time and length of stay for colposuspension.
The procedure time and length of hospital stay for all midurethral slings appears to be similar.
Complications
The most frequently reported complications were bladder perforations, de novo voiding difficulties and device problems.
Quality of Life
Quality of life was not consistently reported in all of the randomized controlled trials. In the studies that reported quality of life there does not appear to be a significant difference in quality of life scores between the sling procedures.
PMCID: PMC3379163  PMID: 23074494
18.  Initial Experience with Concomitant Prolift™ System and Tension-Free Vaginal Tape Procedures in Patients with Stress Urinary Incontinence and Cystocele 
Purpose
The objective of this study is to report our initial experience about the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift™) and concomitant tension-free vaginal tape (TVT) as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI).
Materials and Methods
We reviewed the charts of patients who underwent Prolift™ and TVT between April 2009 and March 2010. All patients had a physical examination and staging of cystocele. According to the International Continence Society system 2, 5 and 3 women had stage grade II, III and IV respectively. All the patients underwent pelvic examination 1, 3, 6 month and 1 year after operation and anatomical and functional outcomes were recorded. An anatomic cure after intervention was defined as stage 0 and an improvement was defined as stage I. Anatomic failures were defined as stage II or higher on the last physical examination.
Results
The mean follow-up was 7.1 (1-11) months. Overall success rate of cystocele repair was 90%. The anatomical cure rate of cystocele was 50%. The cystocele repair improved 4 patients, but failed in 1. SUI was cured in all patients. No significant complications including bladder or vessel injury and mesh related erosion occurred. The postoperative complication was transient voiding difficulty (2 cases).
Conclusions
These preliminary results suggest that Prolift™ and TVT offer a safe and effective treatment for female anterior vaginal wall prolapse and SUI. However, a long-term follow up is necessary in order to support the good result maintenance.
doi:10.5213/inj.2010.14.1.43
PMCID: PMC2989478  PMID: 21120175
Cystocele; Stress urinary incontinence; Treatment
19.  Five Year Follow-Up Comparing Tension-Free Vaginal Tape and Colposuspension 
The Ulster Medical Journal  2007;76(3):146-149.
Burch colposuspension has been the procedure of choice for stress urinary incontinence, more recently the tension-free vaginal tape (TVT) has been used. A retrospective study on all TVT's and colposupensions was performed. The present clinical condition was assessed using the Bristol Female Lower Urinary Tract Symptoms and Short-Form 12 questionnaires. The median operating time was 50-59 minutes for TVT and 70-79 minutes for colposupension. The median number of day's hospitalization was 3 and 10 respectively. The overall success rate was 88.5% and 92% respectively. No significant difference in subjective outcome was noted at more than 5 years after surgery between the two procedures for either the BFLUTS or SF-12.
The initial surgical success for TVT surgery is maintained over a period greater than five years.
PMCID: PMC2075574  PMID: 17853641
20.  Mid-urethral slings in female incontinence: Current status 
The advent of the mid-urethral sling (MUS) 15 years ago has drastically changed the surgical management of stress urinary incontinence (SUI). Both retropubic and transobturator MUS can be placed in the ambulatory setting with excellent results. The tension-free vaginal tape (TVT) sling has the most robust and long-term data, but more recent literature suggests that the transobturator tape sling may offer comparable efficacy in appropriately selected patients. Single incision sling (SIS) is the newest addition to the MUS group and was developed in an attempt to minimize morbidity and create an anti-incontinence procedure that could be performed in the office. The efficacy of SIS remains unknown as the current literature regarding SIS lacks long-term results and comparative trials. The suprapubic arc sling appears to have equally effective outcomes in at least the short-term when compared with TVT. Although evolution of the SIS has led to a less invasive procedure with decreased post-op pain and reduced recovery time, durability of efficacy could be the endpoint we are sacrificing. Until longer-term data and more quality comparison trials are available, tailoring one's choice of MUS to the individual patient and her unique clinical parameters remains the best option.
doi:10.4103/0970-1591.85424
PMCID: PMC3193730  PMID: 22022053
Incontinence surgery; mid-urethral sling; stress urinary incontinence; tension-free vaginal tape; transobturator tape
21.  Comparison of Laparoscopic Burch and Tension-Free Vaginal Tape in Treating Stress Urinary Incontinence in Obese Patients 
Objective:
To compare the efficacy and safety of the tension-free vaginal tape (TVT) and laparoscopic Burch procedures in treating genuine stress urinary incontinence in obese patients.
Methods:
This was a retrospective evaluation of 91 consecutive cases of TVT alone or TVT combined with other procedures from April 1999 through March 2000 and 51 consecutive cases of the laparoscopic Burch procedure from January 1998 through February 1999. All procedures were performed in a private practice and community hospitals in the midwest. One hundred forty-two women (ages 34 to 79) with stress urinary incontinence documented by clinical examination and preoperative cystometric and urodynamic evaluation were included in the study. They were also divided into 5 groups based on their body mass index (BMI): NL (normal-BMI < 25), OW (overweight-BMI 25 to 29), OBI (obesity I-BMI 30 to 34), OBII (obesity II-BMI 35 to 39), OBIII (obesity III-BMI > 40). In the TVT group, 66% were obese (OBI-21, OBII-17, OBIII-22) versus 36% in the laparoscopic Burch (OBI-13, OBII-5) group.
Results:
All TVT patients remain cured or symptoms improved in their genuine stress urinary incontinence, which favorably compares with the laparoscopic Burch procedure after 1 year. Operating time for the TVT portion ranged from 18 to 40 minutes. The laparoscopic Burch procedure in general took over 1 hour. No bladder, bowel, or vascular injuries have occurred in the TVT group. Superficial suprapubic ecchymoses have occurred in the TVT group occasionally but required no intervention. The average length of stay was 1 day; TVT-only patients usually were released on the same day. Ninety percent of patients were voiding normally by postoperative day 7. Most of the patients with continued urinary retention had had combined procedures.
Conclusions:
This preliminary study indicates that TVT is a safer, more effective, and easier minimally invasive surgery for genuine stress urinary incontinence regardless of the patients' BMI and favorably compares with the laparoscopic Burch procedure, which requires advanced surgical skills.
PMCID: PMC3043389  PMID: 12002291
Detrusor Instability; Laparoscopy; Marshall-Marchetti-Krantz; Colposuspension; Tension-free vaginal tape; Stress urinary incontinence in obesity; Minimally invasive surgical procedures; Intrinsic sphincter deficiency
22.  Complications associated with transobturator sling procedures: analysis of 233 consecutive cases with a 27 months follow-up 
BMC Women's Health  2009;9:28.
Backround
The transobturator tape procedure (TOT) is an effective surgical treatment of female stress urinary incontinence. However data concerning safety are rare, follow-up is often less than two years, and complications are probably underreported. The aim of this study was to describe early and late complications associated with TOT procedures and identify risk factors for erosions.
Methods
It was a 27 months follow-up of a cohort of 233 women who underwent TOT with three different types of slings (Aris®, Obtape®, TVT-O®). Follow-up information was available for 225 (96.6%) women.
Results
There were few per operative complications. Forty-eight women (21.3%) reported late complications including de novo or worsening of preexisting urgencies (10.2%), perineal pain (2.2%), de novo dyspareunia (9%), and vaginal erosion (7.6%). The risk of erosion significantly differed between the three types of slings and was 4%, 17% and 0% for Aris®, Obtape® and TVT-O® respectively (P = 0.001). The overall proportion of women satisfied by the procedure was 72.1%. The percentage of women satisfied was significantly lower in women who experienced erosion (29.4%) compared to women who did not (78.4%) (RR 0.14, 95% CI 0.05-0.38, P < 0.001).
Conclusion
Late post operative complications are relatively frequent after TOT and can impair patient's satisfaction. Women should be informed of these potential complications preoperatively and require careful follow-up after the procedure. Choice of the safest sling material is crucial as it is a risk factor for erosion.
doi:10.1186/1472-6874-9-28
PMCID: PMC2760512  PMID: 19781074
23.  A Comparison of the Clinical Efficacy of the Transobturator Adjustable Tape (TOA) and Transobturator Tape (TOT) for Treating Female Stress Urinary Incontinence with Intrinsic Sphincter Deficiency: Short-term Results 
Korean Journal of Urology  2012;53(2):98-103.
Purpose
The transobturator adjustable tape (TOA) allows adjustment of tension after surgical intervention, thus permitting correction of postoperative incontinence or obstruction. The aim of this study was to compare the efficacy and safety of TOA versus transobturator tape (TOT) for the treatment of stress urinary incontinence with intrinsic sphincter deficiency (ISD).
Materials and Methods
Patients underwent TOA (n=33 with ISD) or TOT (n=47 with ISD) insertion by one experienced surgeon. The patients were considered to have ISD on the basis of a Valsalva leak point pressure <60 cmH2O or a maximum urethral closure pressure <20 cmH2O. The preoperative evaluation included history taking, physical examination, voiding diary, stress and 1-hour pad tests, and a comprehensive urodynamic examination. Postoperative evaluation included a stress test, 1-hour pad test, questionnaire, and uroflowmetry with postvoid residuals.
Results
After 6 months of follow-up, the rate of cure (TOA, 75.6% vs. TOT, 72.3%) was similar between the two groups. The rate of satisfaction was not significantly higher in the TOA group than in the TOT group (84.8% vs. 78.7%; p=0.05). Four patients in the TOA group (12.1%) needed a reduction in tension because of urinary obstruction (flow <10 ml/sec and/or residual urine >50 ml). The tension of the mesh was tightened in 5 patients (15.2%) because of the persistence of a certain degree of incontinence. The residual urine volume at postoperative 7 days was significantly lower in the TOA group than in the TOT group (19.5 ml vs. 41 ml; p=0.016, repeated-measures analysis of variance test).
Conclusions
The TOA allows postoperative readjustment of the suburethral sling pressure for a number of days after surgical intervention, which allows for the achievement of good short-term results. These data suggest that better lower obstructive voiding symptoms than those achieved with the traditional nonadjustable mesh can be obtained with the TOA.
doi:10.4111/kju.2012.53.2.98
PMCID: PMC3285716  PMID: 22379588
Stress urinary incontinence; Suburethral slings; Treatment outcome
24.  Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study 
Purpose
The objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI).
Methods
Retropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients.
Results
From January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc® and Ajust® SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P < 0.001) post-operative; TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively).
Conclusions
The SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.
doi:10.1007/s00404-012-2669-8
PMCID: PMC3625405  PMID: 23242512
Female Sexual Function Index; Sexual function; TVT; Single incision sling; Stress; Urinary incontinence; Success rate
25.  TVT-Secur (Hammock) Versus TVT-Obturator: A Randomized Trial of Suburethral Sling Operative Procedures 
Objectives
This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI).
Methods
This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year.
Results
Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3–16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5–128.0) at 12 weeks and 3.5 (95% CI, 1.1–11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36).
Conclusions
The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
doi:10.1097/SPV.0b013e31823bdbcf
PMCID: PMC3712515  PMID: 22453267
TVT-Secur; TVT-Obturator; stress incontinence; efficacy

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