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1.  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
2.  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
3.  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
4.  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
5.  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
6.  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
7.  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
8.  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
9.  Tension-free vaginal tape versus lata fascia sling: The importance of transvulvar ultrasound in the assessment of relevant anatomical parameters in treatment of women with stress urinary incontinence 
Objective:
To describe the relevance of transvulvar ultrasound in the assessment of anatomical differences induced by the lata fascia sling (LFS) and tension-free vaginal tape (TVT) procedures.
Materials and Methods:
Forty women with stress urinary incontinence (SUI), aged 30 to 60 years, have been treated with either LFS (20 patients) or TVT (20 patients). The transvulvar ultrasound of the urethrovesical junction (UVJ) and proximal urethra (PU) has been used as the main investigational tool both pre- and post-operatively. The studied parameters were the vertical (VUVJD) and horizontal (HUVJD) UVJ distances, the pubourethral distance (PUD) and the PU length.
Results:
The VUVJD did not vary significantly after the LFS surgery (P=0.10). The PUD became shorter (P=0.001) and the HUVJD became shorter only at rest (P=0.03) after the correction by LFS. The TVT procedure has led to shortening of the VUVJ displacement (P=0.0005) and of the PU length (P=0.02).
Conclusions:
The transvulvar ultrasound was of utmost importance in the demonstration that both the LFS and TVT surgical procedures elongate the PU, even though the LFS technique does it more efficiently. The LFS technique focus more on shortening the PUD and the TVT procedure focus more on the correction of the vertical UVJ displacement.
doi:10.4103/0970-1591.45539
PMCID: PMC2684306  PMID: 19468431
Fascia Lata Sling Procedure; stress urinary incontinence; tension-free vaginal tape; transvulvar or perineal ultrasound; urethrovesical junction mobility and proximal urethra length
10.  Randomized Controlled Study of MONARC® vs. Tension-free Vaginal Tape Obturator (TVT-O®) in the Treatment of Female Urinary Incontinence: Comparison of 3-Year Cure Rates 
Korean Journal of Urology  2012;53(4):258-262.
Purpose
Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world. However, very few results of randomized clinical trials of transobturator midurethral sling surgery (MONARC vs. TVT-O) for the treatment of female urinary incontinence have been reported. In this study, we compared the 3-year follow-up cure rates of these two procedures.
Materials and Methods
From July 2006 to June 2008, 74 patients who had undergone MONARC (35 patients) or TVT-O (39 patients) were included in the study and were analyzed prospectively. The mean follow-up duration of both groups was 39.2 months. Preoperative and postoperative evaluations included physical examination, uroflowmetry and postvoid residual measurement, involuntary urine loss with physical activity, and urinary symptoms. Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity. The patients' satisfaction after treatment was rated as very satisfied, satisfied, equivocal, and unsatisfied. Very satisfied and satisfied were considered as the satisfied rate.
Results
There were no significant differences in preoperative patient characteristics, postoperative complications, or success rate between the two groups. The cure rate of the MONARC and TVT-O groups was 85.7% and 84.6%, respectively. The patient satisfaction (very satisfied, satisfied) rate of the MONARC and TVT-O groups was 82.8% and 82.1%, respectively.
Conclusions
The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence, with maintenance of high cure rates for 3 years. Longer follow-up is needed to confirm these results.
doi:10.4111/kju.2012.53.4.258
PMCID: PMC3332137  PMID: 22536469
Urinary incontinence; Suburethral sling; Suburethral slings
11.  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
12.  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
13.  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
14.  Protocol for Physiotherapy OR Tvt Randomised Efficacy Trial (PORTRET): a multicentre randomised controlled trial to assess the cost-effectiveness of the tension free vaginal tape versus pelvic floor muscle training in women with symptomatic moderate to severe stress urinary incontinence 
BMC Women's Health  2009;9:24.
Background
Stress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report that their condition improved, but long term adherence to treatment is problematic. In addition, at longer term (2-15 years) follow-up 30-50% of patients will end up having surgery. From 1996 a minimal invasive surgical procedure, the Tension-free Vaginal Tape (TVT) has rapidly become the gold standard in surgical treatment of stress urinary incontinence. With TVT 65-95% of women are cured. However, approximately 3-6% of women will develop symptoms of an overactive bladder, resulting in reduced quality of life. Because of its efficacy the TVT appears to be preferable over PFMT but both treatments and their costs have not been compared head-to-head in a randomised clinical trial.
Methods/Design
A multi-centre randomised controlled trial will be performed for women between 35 - 80 years old with moderate to severe, predominantly stress, urinary incontinence, who have not received specialised PFMT or previous anti-incontinence surgery. Women will be assigned to either PFMT by a specialised physiotherapist for a standard of 9-18 session in a period of 6 months, or TVT(O) surgery. The main endpoint of the study is the subjective improvement of urinary incontinence. As secondary outcome the objective cure will be assessed from history and clinical parameters. Subjective improvement in quality of life will be measured by generic (EQ-5D) and disease-specific (Urinary Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments. The economical endpoint is short term (1 year) incremental cost-effectiveness in terms of costs per additional year free of urinary incontinence and costs per Quality Adjusted Life Years (QALY) gained. Finally, treatment strategy and patient characteristics will be combined in a prediction model, to allow for individual treatment decisions in future patients. Four hundred female patients will be recruited from over 30 hospitals in the Netherlands
Trial registration
Nederlands trial register: NTR 1248
doi:10.1186/1472-6874-9-24
PMCID: PMC2749818  PMID: 19723313
15.  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
16.  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
17.  Analysis of 1,000 cases of synthetic midurethral slings used for treatment of female urinary incontinence – a single-center experience 
Introduction
This study summarized our experience in the treatment of 1,081 women with stress urinary incontinence (SUI) using mid-urethral slings.
Material and methods
The study included 1,081 operated patients. Pure SUI was diagnosed in 77.80% (841) of the patients; another 18.68% (202) had mixed symptoms. The remaining 3.52% (38) suffered from recurrent SUI. Group 1 included the SUI patients treated with TVT. Group 2 – SUI managed with TVT-O. In Group 3, mixed urinary incontinent (MUI) patients were treated with TVT-O.
Results
Retropubic TVT was used in 273 patients (25.25%) and TVT-O in 740 (68.45%). Other slings were used in 68 patients (6.3%). Mean follow-up for the groups was 50.1, 31.1, and 32.6 months respectively. For objective evaluation of cure rate we used the cough stress test. Subjective efficacy was studied via a visual analog scale. The complication rate in each group of the patients was used as a secondary end point. A negative cough test was found in 85.58% of patients in Group 1. For the TVT-O group, the objective cure rate was 84.36%. Intra-operative complications for TVT and TVT-O were not related to age, BMI, or parity. Bladder perforation and pelvic hematoma developed more frequently in the TVT group. There is a higher risk of vaginal perforation for TVT-O. The objective and subjective cure rates for MUI patients were 86.15% and 87.69% respectively.
Conclusions
TVT and TVT-O are equally effective and safe methods of treatment for women suffering from SUI and MUI.
doi:10.5173/ceju.2011.04.art13
PMCID: PMC3921747  PMID: 24578904
TVT; TVT-O; tension-free tape; stress urinary incontinence
18.  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
19.  Operative shortening of the sling as a second-line treatment after TVT failure 
Introduction
Stress urinary incontinence (SUI) is defined as an involuntary loss of urine during physical exertion, sneezing, coughing, laughing, or other activities that put pressure on the bladder. In some cases, recurrent or persistent SUI after sling operations may be caused by too loose placement of the sling. In the current study, we describe our method of shortening of the sling as a second-line treatment of tension-free vaginal tape (TVT) failure.
Materials and methods
Four women, aged 46-61, after initial TVT operation were treated for persistent SUI. The severity of SUI was estimated by: physical examinations, cough tests, 24-h pad tests, and King's Health Questionnaire. The shortening procedure, based on excising the fragment of tape and suturing it back, was performed in all patients.
Results
All cases achieved a good result, which was defined as restoration of full continence. No complications occurred. The 12-month follow-up showed no side-effects. The postoperative control tests: the cough and 24-h pad tests were negative in all women. The general health perceptions increased after the shortening procedure by a mean value 44.25%. The incontinence impact decreased by a mean value 44.6%. In all patients, role and physical limitations significantly decreased (by 88.5% and 80.5%, respectively). The negative emotions connected with SUI significantly decreased after the second procedure.
Conclusions
The operative shortening of the implanted sling is a simple, cheap, and effective method of second-line treatment in cases of TVT failure and may be offered to the majority of patients with insufficient urethral support after the first procedure.
doi:10.5173/ceju.2011.03.art14
PMCID: PMC3921729  PMID: 24578885
female; stress urinary incontinence; midurethral sling; TVT failure
20.  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
21.  Tape Shortening for Recurrent Stress Urinary Incontinence After Transobturator Tape Sling: 3-Year Follow-up Results 
Purpose
Recently, as the number of transobturator tape (TOT) procedures has increased, recurrence after this procedure has been frequently reported. However, there are no standard guidelines for treatment. We describe our experience with shortening the previously implanted tape in patients with recurrent stress urinary incontinence after the TOT procedure.
Materials and Methods
We enrolled 10 women who underwent shortening of the previously implanted tape and were followed up for 3 years. Shortening of the previously implanted tape was done by a figure-eight suture with 1-0 Prolene. One year after TOT shortening, we investigated continence status, patient satisfaction by means of a questionnaire, maximal flow rate (Qmax), and postvoid residual urine volume. Three years after TOT shortening, we evaluated continence status and patient satisfaction.
Results
The mean period of TOT shortening was 4.2 months (range, 1-12 months) after the TOT procedure. One year after TOT shortening, 7 patients showed complete dryness, 2 patients showed improvement, and 1 patient reported failure. Eight patients were very satisfied or satisfied with the 1-year result after TOT shortening. The mean preoperative and postoperative Qmax were 23.8 and 26.7ml/s, respectively, and there was no significant difference. Three years after TOT shortening, 6 patients showed complete dryness, 2 patients showed improvement, and 2 patients reported failure. Among them,1 had failed from 1 year after TOT shortening and the other had shown 1 year of complete dryness. Eight patients were very satisfied or satisfied and 2 patients were dissatisfied with the 3-year result after TOT shortening.
Conclusion
Most of the patients who underwent TOT shortening reported satisfaction as well as improvement of incontinence after a 3-year follow up. Therefore, we suggest that TOT shortening may be recommended primarily in patients with recurrent stress urinary incontinence after the TOT sling procedure.
doi:10.5213/inj.2010.14.3.164
PMCID: PMC2998403  PMID: 21179334
Urinary stress incontinence; Suburethral sling; Transobturator tape
22.  Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial 
Background
Many women without preexisting stress urinary incontinence (SUI) who undergo vaginal surgery to correct pelvic organ prolapse will develop symptoms of SUI. A concomitant prophylactic anti-incontinence procedure may prevent SUI symptom development in women undergoing vaginal prolapse surgery.
Purpose
To present the rationale, design and methodology of a randomized controlled surgical trial (RCT), the Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial. The primary aims of this RCT are to determine (1) whether the prevalence of post-operative urinary incontinence (UI) differs between stress continent women receiving vaginal prolapse repair with concomitant tension-free vaginal tape (TVT®; a sling procedure commonly used to treat SUI) and those with only sham incisions at 3 months post surgery (2) whether it is more cost-effective to place a TVT prophylactically than to treat the SUI symptoms postoperatively as they occur over a 12 month period after the index surgery.. The study also incorporates a patient preference trial (PPT).
Methods
Primary outcome, defined as signs (positive cough stress test), symptoms (per validated questionnaire) and/or need for treatment of SUI and its associated cost, at 3 and 12 months post-operatively. Secondary outcomes consist of group differences in lower urinary tract and prolapse symptoms, health related quality of life, measures of vaginal anatomy, and surgical complications.
Limitations
Given the invasive nature of surgical intervention trials, some individuals may be reluctant to agree with random assignment, potentially impacting result generalizability. To evaluate the magnitude and direction of non-participation bias, the PPT will enroll a sample of those who decline participation in the RCT but are otherwise eligible.
Conclusion
This sham-controlled RCT will provide important information for patients and surgeons regarding both the short- and long-term optimal treatment approach for stress continent women undergoing a vaginal surgery for prolapse. Non-participation bias will be estimated.
doi:10.1177/1740774509102605
PMCID: PMC2878478  PMID: 19342469
Stress Urinary Incontinence; Pelvic Organ Prolapse; Surgical Intervention; Mid-urethral slings; Tension-free Vaginal Tape; Prophylactic Incontinence Procedure; Patient Preference Trial; Randomized Controlled Trial
23.  Tension-Free Vaginal Tape, Transobturator Tape, and Own Modification of Transobturator Tape in the Treatment of Female Stress Urinary Incontinence: Comparative Analysis 
BioMed Research International  2014;2014:347856.
Introduction. This study is a comparative evaluation of the TVT, TOT, and our own modification of TOT (mTOT) in the treatment of female stress urinary incontinence from a single center experience. Material and Methods. The study was conducted on 527 patients with SUI diagnosed on the basis of urodynamic studies. They were divided into three groups—TVT: n = 142, (TOT): n = 129, and mTOT: n = 256. All of the patients underwent evaluation at 1, 3, and 6 months after surgery. Results were statistically analysed and compared. Results. Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from 90.1% to 96.4%. Mean surgery time was 32.3, 28.2, and 26.4 in the TVT, TOT, and mTOT, respectively. Mean hospitalization time was 2.51 days. Mean catheter maintenance time was significantly higher in the TVT than in other groups. In the TVT group total incidence of complications was 13.4%, and it was significantly higher than that in TOT and mTOT (9.3% and 8.6%, resp.). Conclusions. TVT, TOT, and mTOT are highly effective and safe methods in the treatment of SUI. There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group.
doi:10.1155/2014/347856
PMCID: PMC3976787  PMID: 24745013
24.  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
25.  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

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