Related Articles

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

This study was undertaken to identify risk factors for postoperative voiding dysfunction and factors having impact on patient global satisfaction after a tension-free vaginal tape (TVT) procedure. Two hundred and eighty-five women who underwent the TVT procedure for stress urinary incontinence were analyzed to identify risk factors predictive of voiding dysfunction. Postoperative voiding dysfunction was defined as a peak urinary flow rate (PFR) <10 mL/sec (straining voiding, n=17) or residual urine volume >30% of bladder capacity (incomplete emptying, n=13). The global satisfaction rate was 91.6%. Voiding dysfunction developed in 29 (10.2%) patients. Among the factors, PFR was only factor of significance for voiding dysfunction. There was no significant difference between patients with and without voiding dysfunction in terms of their satisfaction. But postoperative PFR <10 mL/sec significantly compromised global satisfaction after the surgery. In those patients with a preoperative PFR <20 mL/sec, there were more patients with postoperative PFR <10 mL/sec. Peak urinary flow rate is an important factor for the postoperative voiding dysfunction. The inevitable decline in PFR can compromise patients' satisfaction with the procedure, when their postoperative PFR was <10 mL/sec.

Purpose

We compared outcomes of the U- and H-type approaches of the tension-free vaginal tape (TVT)-Secur procedure for the treatment of female stress urinary incontinence (SUI).

Materials and Methods

From March 2007 to July 2008, 115 women with SUI underwent TVT-Secur by a single surgeon. Patients were randomly assigned to either the U- or the H-type approach. After 12 months, postoperative changes in the Sandvik questionnaire, incontinence quality of life questionnaire (I-QoL), Bristol female lower urinary tract symptoms-scored form (BFLUTS-SF), and postoperative patient satisfaction were evaluated. Cure was regarded as no leakage on the Sandvik questionnaire. Complications were also evaluated.

Results

Of 115 women, 53 were treated with the U approach, and 62 women were treated with the H approach. At 12 months, 88.7% of those treated with the U approach and 87.1% of those treated with the H approach were cured (p=0.796). The I-QoL and filling, incontinence, sexual function, and QoL sum (BFLUTS-SF) scores were improved with both approaches, and there were no significant differences in the degree of improvement between approaches. Approximately 83.7% and 82.9% of the women treated with the U and H approaches, respectively, were satisfied with the outcome (p=0.858). There were 3 cases of intra-operative vaginal wall perforation in the H-type group. Immediate postoperative retention was observed in 2 women in the U-type group and 1 woman in the H-type group. One woman in the U-type group underwent tape releasing and cutting procedures for persistent large post-void residuals.

Conclusions

The U- and the H-type approaches of the TVT-Secur procedure provided comparable effectiveness for the treatment of female SUI.

Purpose

We assessed the long-term effects of the tension-free vaginal tape (TVT) procedure for stress urinary incontinence (SUI) on voiding, storage, and patient satisfaction.

Materials and Methods

This retrospective study examined the records of 134 patients who had undergone the TVT procedure for SUI and were followed up for more than 5 years. Voiding function was evaluated by measuring maximum urinary flow rate (MFR), post-void residual urine volume (PVR), and storage function by using a voiding diary. Patients were asked to describe their satisfaction with the operation.

Results

MFR was lower at 1 month compared with the preoperative level, but had recovered to preoperative levels by 5 years postoperatively. However, some patients with >50%, 25-50%, and <25% decreases in the MFR at 1 month postoperatively showed a decrease in the MFR of >50% at 5 years. PVR increased over the 5 postoperative years. Of the patients with urgency and urgency incontinence, 43.8% and 48.1% showed improvement, respectively, whereas new patients developed postoperatively. Thus, the total number of patients with urgency or urgency incontinence remained similar over the 5 years. In those with a changed voiding pattern, patient satisfaction was negatively affected by de novo urgency and urgency incontinence and decreased MFR.

Conclusions

Any obstructive effect of the TVT procedure diminished over time in most patients, although a decrease in the MFR was sustained in some patients. With regard to overactive bladder symptoms, some patients were cured and some patients complained of de novo symptoms. The most major factor affecting patient satisfaction was de novo urgency.

Aims and Objectives:

To evaluate the outcome of suburethral and transobturator sling in treatment of female stress urinary incontinence in 209 cases from 2002 to 2010. The criteria evaluated were success, failure, complications, operating time, ease of the procedure, availability and cost effectivity of the sling.

Design and Setting:

A retrospective comparative study was carried out at a tertiary referral centre for female urinary incontinence.

Material and Methods:

A total of 209 patients (females from 27 to 79 years of age) with proven stress urinary incontinence were treated by suburethral transvaginal tape (TVT) type of slings in 101 cases and transobturator Monarc type of sling in 108 cases at the National Institute of Endoscopic Surgery and Urinary Incontinence Center, Mumbai, India, from March 2002 to June 2010. The maximum follow up was for 8 years.

Results:

The TVT type of slings had higher complication rate like needle entering the bladder, retention of urine necessitating to cut the tape in the center and had a success rate of 94.5% compared to Monarc/Trivedi obturator tape (TrOT) type of sling with outside-in technique, which had a negligible complication (less than 1%), pain in groin or leg movement that reduced in 6 weeks and a success rate of 95%. Specially, the Indian design Trivedi’s stress urinary incontinence tape (TSUIT) and TrOT with reusable needles, the cost was only 15–20% of the international brands.