Tension-free Vaginal Tape Operation Research Articles

NOVEL RECTUS CROSSOVER TECHNIQUE FOR ENHANCING CONTINENCE IN CUTANEOUS URINARY DIVERSION

We evaluated the long-term outcome of the Pippi Salle procedure in patients with severe intrinsic urethral sphincter deficiency.We performed the Pippi Salle procedure in 6 males and 6 females with severe intrinsic sphincter deficiency between March 2003 and August 2013. Median patient age was 15 years (range 6 to 45). Mean followup was 75 months (range 17 to 142). Six males and 3 females had neurogenic intrinsic sphincter deficiency (spina bifida in 8 and spinal cord injury in 1). Three females had anatomical intrinsic sphincter deficiency (idiopathic bladder hypoplasia in 2 and pseudo-ureterocele in 1). Four patients had previously undergone bladder neck surgery, 3 had been treated with endoscopic injection of collagen, 2 had undergone fascial sling and 1 had been treated with tension-free vaginal tape surgery. The Pippi Salle procedure was performed alone (2 patients), or in combination with bladder augmentation (4) or catheterizable abdominal stoma (1), or both (5).Complete dryness was achieved in 7 patients (58%). Of 9 patients with neurogenic intrinsic sphincter deficiency 7 (78%) achieved complete dryness. Eight patients experienced complications, including continued urinary incontinence (5), difficulty catheterizing per urethra (3) and urinary calculi (1). These 8 patients were successfully treated with additional endoscopic interventions, including injection of collagen in 4, injection of dextranomer-hyaluronic acid in 1, transurethral incision of urethral kink in 3 and vesicolithotripsy in 1. After these simple interventions complete dryness was achieved in all 12 patients.Although we experienced some minor complications in the short term, most patients were simply and successfully treated with endoscopic surgery. The long-term results of the Pippi Salle procedure are promising.

Effectiveness of the TVT procedure as a repeat mid-urethra operation for treatment of stress incontinence

INTRODUCTION AND HYPOTHESES: The aim was to evaluate the long-term (5 years) effect of performing a retropubic tension-free vaginal tape (TVT) operation after a prior failed mid-urethra sling procedure and try to identify reasons for failure of the primary operation. We identified 26 women to whom a repeat mid-urethra sling procedure (using the TVT Gynecare device) had been performed. Both the primary and repeat operations were retropubic procedures. Four different tape materials had been utilized in the primary procedure. Twenty women (77%) of the identified 26 women participated in the study. Seventy-five percent of the women were cured or significantly improved after the repeat TVT procedure. Reasons for failure of the primary procedure were grouped as follows: inadequate tape material (four out of 20), inadequate surgical technique (six out of 20), patients' medical condition (four out of 20), and unrecognized reasons (six out of 20). A retropubic mid-urethra sling operation can be considered after failed mid-urethra sling surgery.

Long-term outcomes of TVT and IVS operations for treatment of female stress urinary incontinence: monofilament vs. multifilament polypropylene tape

We compared cure rates of tension-free vaginal tape (TVT) with intravaginal slingplasty (IVS) and evaluated changes in cure rates over time. One hundred three underwent TVT and 213 underwent IVS. Follow-ups were done at 3 months, 1 year, and 5 years. The following results were found: objective cure for TVT 98-95-94% vs. IVS 86-86-80% (p < 0.03); subjective cure for TVT 82-79-74% vs. IVS 79-81-71% (NS). In IVS, a significant decline in subjective cure took place. Vaginal erosions were found in 11.8% of women in the IVS group and none in the TVT group. TVT is an effective and stable treatment, whereas IVS has a significant inferior objective cure rate, and a significant decline in subjective cure rate occurred over time. A high rate of vaginal erosions was found in the IVS group. We cannot recommend the use of multifilament polypropylene tape (IVS) for surgical treatment of stress urinary incontinence.

Responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF)

This study aimed to evaluate the responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF) in women undergoing surgery for pelvic floor disorders. Fifty-four women undergoing tension-free vaginal tape (TVT) and 47 women undergoing prolapse surgery completed ePAQ-PF at baseline and 3 months postoperatively. Responsiveness was calculated using effect sizes, standardized response means, responsiveness statistic, and minimally important difference. In the TVT group, the largest effect sizes were seen in the urinary domains for stress urinary incontinence (2.4), quality of life (2.2), and overactive bladder (0.9). In the prolapse group, the largest effect sizes were seen in the vaginal domains for prolapse (2.1) and quality of life (1.0). ePAQ-PF is responsive to change in women undergoing TVT or prolapse surgery in the salient and expected domains of stress incontinence and prolapse and quality of life and can be recommended for outcome measurement in this context.

Pre‐operative opening detrusor pressure is predictive of detrusor overactivity following TVT in patients with pre‐operative mixed urinary incontinence

To determine if specific pre-operative urodynamic parameters could predict detrusor overactivity following TVT in patients with urodynamic mixed incontinence. Notes of women with detrusor overactivity (DO) and urodynamic stress incontinence (USI) before undergoing tension-free vaginal tape (TVT) surgery were retrospectively reviewed. Patients underwent clinical evaluation pre-operatively including history, examination, and conventional urodynamic studies and were treated with pelvic floor exercises and anti-cholinergic medication. Those with persistent stress urinary incontinence (SUI) underwent TVT. Patients were re-assessed after at least 6 months post-operatively. Pre- and post-operative opening and closing detrusor pressure, and detrusor pressure at maximum flow were recorded retrospectively from pre-operative urodynamics traces by two clinicians independently and compared to the patients' post-operative symptoms and urodynamic diagnosis. Fifty-one women were reviewed. Forty-six of the 51 attended follow-up and 35/51 agreed to conventional urodynamic studies. Seventeen of the 35 reported OAB symptoms, and 18/35 were asymptomatic. Nineteen of the 35 women had DO and 16/35 had normal urodynamic studies (NUDS). The median pre-operative opening detrusor pressure was higher in women with overactive bladder symptoms post-operatively. The median pre-operative opening detrusor pressure in women with DO post-operatively was 33.0 cmH(2)O and the median pre-operative opening detrusor pressure in those with NUDS post-operatively was 16 cmH(2)O (15.0-23.0 cmH(2)O) (P < 0.05 Mann-Whitney U-test). Higher numbers of patients are required to demonstrate the value of opening detrusor pressure in predicting post-operative overactive bladder symptoms. Opening detrusor pressure is predictive of post-operative DO after TVT.

Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up

The objective of the study was to obtain a prospective assessment of the efficacy and the complications associated with the use of tension-free vaginal tape (TVT) for the management of urodynamic stress incontinence at 5- and 7-year follow-up. Sixty-five female patients with stage I cystocele or less who have been operated with TVT procedure for management of urodynamic stress incontinence have been included in the study. At 5-year follow-up, the objective cure rate was 83% and failure rate 9.4%. At 7-year follow-up, the objective cure rate was 80% and the failure rate 13.5%. De novo detrusor overactivity was seen in 9.4% and 11.4% of patients at 5- and 7-year follow-up, respectively. TVT operation is an effective and safe minimally invasive procedure for the management of urodynamic stress incontinence in women without significant cystocele in the long-term follow-up. The 10- and 20-year results are awaited.

Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence

The aim of this study was to evaluate the long-term effectiveness and safety of the tension-free vaginal tape (TVT) procedure. In a Nordic three-center prospective observational cohort study, 90 women with primary stress incontinence had a TVT operation performed in local anesthesia. Assessment included a 24-h pad test, a stress test, physical examination, and a visual analog scale for assessing the degree of bother. Patient's global impression of cure was obtained, and condition specific quality of life questionnaires were used. Seventy-seven percent of the initial cohort of 90 women and 89% of those alive and capable of cooperating were assessed 11.5 years after the TVT operation. Ninety percent of the women had both a negative stress test and a negative pad test being objectively cured. Subjective cure by patients global impression was found in 77%, 20% being improved and only 3% regarded the operation as a failure. No late-onset adverse effects of the operation were found, and no case of tape erosion was seen. The TVT procedure is safe and effective for more than 10 years.

Erratum

Neurourology and UrodynamicsVolume 27, Issue 4 p. 360-360 ErratumFree Access Erratum Dr S Kulseng-Hanssen, Dr S Kulseng-HanssenSearch for more papers by this authorDr H Husby, Dr H HusbySearch for more papers by this authorDr HA Schiotz, Dr HA SchiotzSearch for more papers by this author Dr S Kulseng-Hanssen, Dr S Kulseng-HanssenSearch for more papers by this authorDr H Husby, Dr H HusbySearch for more papers by this authorDr HA Schiotz, Dr HA SchiotzSearch for more papers by this author First published: 10 April 2008 https://doi.org/10.1002/nau.20597AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume27, Issue4April 2008Pages 360-360 ReferencesRelatedInformation

Transobturator Suburethral Tapes in the Management of Urinary Incontinence: Success, Safety and Impact on Sexual Life

The tension-free vaginal tape (TVT) procedure has, in the past decade, become the most popular treatment for urodynamic stress incontinence (USI). A variant of the TVT operation is the transobturator tension-free vaginal tape (TOT) procedure, of which there are 2 forms: Obtape (the outside-in technique) and TVT-0 (the inside-out technique). This retrospective study compared the efficacy and safety of the 2 TOT procedures and their effects, if any, on patients' sexual lives. Participants were 94 women with USI or mixed incontinence who had the TVT-0 operation at a tertiary referral center in Scotland in the years 2002-2005 and 182 others having the Obtape procedure. The mean age was 49 years, and mean parity was 2. The 2 groups did not differ significantly with regard to body mass index, urodynamic diagnosis, or previous incontinence surgery. Evaluative instruments included the urinary domain of the Birmingham Bowel and Urinary Symptoms Questionnaire, the International Consultation on Incontinence Questionnaire Short Form, the Sexual Impact Questionnaire, and a visual analogue scale to estimate patient satisfaction. After a median follow-up interval of 28 months, the success rates-as estimated subjectively and based on no or only occasional episodes of incontinence-were 86% in patients with USI and 52% in those with mixed incontinence (P < 0.001). Urgency became worse postoperatively in 8% of patients. Rates of bladder and urethral injury were less than 1%, and there were no significant differences in intraoperative or early postoperative complications between the 2 surgical groups. Late postoperative complications were significantly more frequent in the Obtape group and included de novo urgency and vaginal erosions. No substantial change was found in the frequency of intercourse and pleasure or pain during penetration. Coital incontinence declined significantly after surgery. Only 13% of women described sexual intercourse as being worse or much worse after surgery. About 8% of patients experienced vaginal dryness that caused discomfort. The TOT operation is an effective and relatively safe treatment for USI. The vast majority of women in this study reported improvement or no change in their sexual lives. Overall complication rates were similarly frequent with the inside-out and outside-in procedures, but there were significantly more tape-related complications after use of the Obtape (outside-in) technique.

Sling de aponeurose e com faixa sintética sem tensão para o tratamento cirúrgico da incontinência urinária de esforço feminina

to compare sling operations of aponeurosis and tension-free vaginal tape (TVT) for the correction of stress urinary incontinence (SUI) regarding: the rates of subjective and objective healing, the mobility of the bladder neck with ultrasonography, the variation of the absorbent test, the urodynamic alterations and the incidence of complications. eighty patients with SUI were selected. Among them, 61 underwent a TVT surgery and 19, an abdominal rectum sling operation of aponeurosis. Average age, index of body mass and parity were 50.1 years old, 29.7 kg/m(2) and 4.1 deliveries (median=3) for the patients with aponeurosis sling, and 51.7 years old, 28.1 kg/m(2) and 4.1 deliveries (median=3) for the ones with TVT. All of them have undergone anamnesis, physical examination, bladder neck ultrasonography, absorbent test and urodynamic evaluation before and at least six months after the surgery. After 15 or 19 months and after about four or five years, they were again interviewed concerning the surgery results. after six months, 96.7% of the women with TVT and 89.5% of the ones with sling thought they were healed in the subjective evaluation. Nevertheless, after 15 to 19 months, the TVT Group kept the same subjective healing rate, while among the Sling Group the rate decreased to 77.8%. There was a significant decrease in the mobility of the neck bladder that was similar in both groups and an improvement in the absorbent test. At the end of the urodynamic study, 93.4% of the women from the TVT Group and 78.9% of the ones from the Sling Group were classified as having an objective healing. The average time of bladder probing was higher in the Sling Group. Urinary retention was observed in 42.1% of the sling cases and in 9.8% of the TVT's. The rates of late healing were 90% for TVT and 55.6% for sling. TVT surgery provided better subjective healing after 15 or 19 months, but the rate of objective healing was the same in both techniques at that time. Among the complications detected, the urinary retention was higher in the Sling Group, in the post-surgery period.

Tape functionality: Sonographic tape characteristics and outcome after TVT incontinence surgery

To investigate tension-free vaginal tape (TVT) position and shape using ultrasound (US) and correlate the findings to outcome. The results of TVT surgery were investigated in 72 women with urodynamic stress urinary incontinence. The main outcome parameters were US tape position in relation to the urethra and dynamic changes in TVT shape at rest and during straining. Sixty-two patients (86%) were continent, 6 (8%) significantly improved, and the operation failed in four cases (6%). The median tape position was at 66% of the urethral length measured by US. The median tape-urethra-lumen distance was 3.8 mm at rest. Tape placement in the upper or lower quarter of the urethra was associated with a higher failure rate. Tapes positioned less than 3 mm from the urethra significantly increased postoperative complications (P < 0.0001). The tape was flat at rest and curved during straining in 44 (61%) patients; 98% (43/44) of these women were continent after surgery. An unchanged tape shape was associated with a poorer outcome (P = 0.00038). Patients with a flat tape at rest and during straining failed in 25% and patients with a permanent curved shape in 10%. TVT position relative to the patient's urethra seems to play a role in treatment outcome. Outcome was best in patients with dynamic change in tape shape during straining and location of the tape at the junction between the lower and middle urethra and at least 3 mm from the urethral lumen.

Duloxetine 1 year on: the long-term outcome of a cohort of women prescribed duloxetine

This aim of this study was to determine the long-term persistence with duloxetine in a cohort of women treated for stress incontinence and any alternative treatments undertaken. Two hundred twenty-eight women prescribed duloxetine were initially reviewed after 4 weeks of treatment. Women continuing therapy were reassessed at 4 and 6 months and 1 year with a review of all treatments after 1 year. At each visit, they were asked about persistence with duloxetine, reasons for discontinuation and any alternative treatments. Seventy-one (31%) women continued beyond 4 weeks of treatment, and twenty-six (12%) were taking duloxetine 4 months later, 23 (10%) at 6 months and 21 (9%) at 1 year. One year later, 187 (82%) women had a tension-free vaginal tape operation (TVT). The majority of women discontinued because of side effects (56%) or lack of efficacy (33%). Few women persevere with duloxetine beyond 4 months. One year later, the majority of women had a TVT.

The Effects of Simultaneous Vaginal Hysterectomy on the Outcomes of a Tension-free Vaginal Tape Procedure for Female Stress Urinary Incontinence

Korea Purpose: Hysterectomy, regardless of the surgical technique, increases the risk of having to undergo stress urinary incontinence surgery later in life. Furthermore, transvaginal hysterectomy may cause some changes in the normal architecture and tension of the tissues surrounding the pelvic floor, and this may also cause some changes in the continence mechanisms of the bladder and urethra. We investigated if there are any adverse effects of concomitant vaginal hysterectomy on the outcomes of a tension-free vaginal tape procedure. Materials and Methods: The outcomes of the tension-free vaginal tape (TVT)/transvaginal total hysterectomy (VTH) group were compared with that of the TVT group in terms of cure and improvement of incontinence, satisfaction with the procedure and the complications. The preoperative evaluation included history taking, physical examination and stress tests and determining the stress-related leakage, the emptying ability, the anatomy, the protection and the inhibition (SEAPI) scores. The outcomes were evaluated at over one year after operation. Results: The cure and improvement rates were 77.5% and 15% in the TVT group, and 88.9% and 7.4% in the TVT/VTH group, respectively, without any statistical difference between the two groups. The rates of patientsatisfaction with the procedure were similar in two groups. There were no serious or long term complications related to the procedure except for a case of local hematoma in the hysterectomy site, which was controlled conservatively. Conclusions: Our findings suggest that a TVT operation can be done simultaneously with vaginal hysterectomy with similar results as those of TVT operation only. In addition, it is thought that the simultaneous TVT operation in a patient who is undergoing hysterectomy and has urinary stress incontinence deserves to be recommended in a positive light. (Korean J Urol 2008;49:850-854)

Tension-Free Vaginal Tape Obturator: Midterm Data on an Operative Procedure for the Cure of Female Stress Urinary Incontinence Performed on 100 Patients

Study Objective To evaluate the midterm therapeutic results of a minimally invasive anti-incontinence operative procedure, the tension-free vaginal tape (TVT) obturator. Design With this prospective, observational, and consecutive patient series, the TVT obturator procedure was performed by the same surgeon on 100 patients. Follow-up lasted 30 to 36 months. Setting Operative theaters of Assuta medical centers private hospitals. Patients One hundred female patients with urodynamically proven stress urinary incontinence. Interventions TVT obturator operations were performed for all patients. Measurements and Main Results Demographic and therapeutic aspects of the patient group data were evaluated. Clinical signs for bowel, urethral, or bladder injuries were undetectable with this TVT obturator patient group. Intraoperative bleeding, postoperative field infections, or postoperative pelvic floor relaxations were not noted. The therapeutic failure rate for the TVT obturator procedure was 8.0% (8 of 100 patients) after 1 year, whereas the midterm failure rate was 10.8% (10 of 93 patients). Six of the 10 patients with TVT obturator failure underwent interval TVT operations with satisfactory results. The overall midterm satisfaction rate for this study group of patients was 89.2% (83 of 93 patients), 6 (6.5%) of those patients were improved only, yet still with minimal residual urinary leakage. Conclusion Use of the TVT obturator, a midurethral sling, did not involve bladder penetration and was complicated by a low rate of postoperative outlet obstruction. The midterm therapeutic results and the cost-effectiveness of the TVT obturator appear similar to previously reported midurethral sling operations. Long-term comparative data collection is required to enable drawing solid conclusions regarding the appropriate position of this operative technique within the spectrum of antiincontinence operations.

Predictors of Success With Postoperative Voiding Trials After a Mid Urethral Sling Procedure

We identified predictors of passing a voiding trial after incontinence surgery with a mid urethral sling and examined if successful performance on a voiding trial was maintained. A total of 89 women scheduled for incontinence surgery were enrolled from July 2005 until April 2006. Voiding trials were performed the day of discharge from the hospital, with a two-thirds volume void after a 300 ml fill considered passing. Those who passed underwent a second voiding trial 3 hours later. Of the participants 60 (67.4%) underwent tension-free vaginal tape surgery, 29 underwent transobturator tape (32.6%) and 64 (71.9%) underwent concurrent vaginal repairs. A total of 59 (67.0%) participants passed the first voiding trial. Univariate analysis identified 12 potential predicting variables for passing the first voiding trial. From these 12, model building via backward stepwise logistic regression found maximum flow on preoperative uroflowmetry to be the only significant predictive variable (p = 0.0002). Of the 59 women who passed the initial voiding trial 9 (16.4%) failed the second voiding trial. None of the 11 participants who had maximal flow rates greater than 30 cc per second failed the first or second voiding trial, whereas 17 of 22 subjects (77.3%) who had maximal flow rates less than 15 cc per second failed either of these trials. Maximum flow rates on preoperative uroflowmetry were the best predictor of passing an initial voiding trial after undergoing a mid urethral sling procedure for incontinence. However, the ability to maintain performance on a second voiding trial, even only 3 hours after passing an initial trial, is not assured.

Follow-up of TVT operations in 1,113 women with mixed urinary incontinence at 7 and 38 months

A follow-up was done 7 and 38 months after tension-free vaginal tape (TVT) operation in 1,113 women with mixed urinary incontinence. Mixed incontinence and predominant bother were subjectively defined. The results were analyzed according to the women's predominant bother: stress incontinence, urge incontinence, or stress and urge incontinence equally. Across the groups, stress incontinence was cured in 87 and 83% of the women at 7 and 38 months, respectively, with no difference between the three groups. Women with predominant stress incontinence had significantly better results at both 7 and 38 months than those in the other groups, especially those predominantly bothered by urge incontinence. Women with mixed incontinence were significantly more often cured both objectively and subjectively at 7 than 38 months. Only 11% of the women experienced an increase in urge incontinence 38 months after TVT. Before a TVT operation, women with mixed urinary incontinence should be informed that their prognosis depends on their predominant bother. TVT is an appropriate treatment in mixed urinary incontinence, but women with predominant urge incontinence have poorer results than those with predominant stress incontinence.

Continuous urinary incontinence presenting as the initial symptoms demonstrating acontractile detrusor and intrinsic sphincter deficiency in multiple system atrophy

Severe stress incontinence due to intrinsic sphincter deficiency may be common in aged women. However stress urinary incontinence could be the initial symptom of severe neurogenic bladder even if no neurological signs have previously been recognized. Urodynamic study is necessary in such a case. Tension-free vaginal tape surgery and intermittent self-catheterization may be one option, but self catheterization might become difficult when the neurological disorders develop. In this case report, we highlight the need for caution in identifying the presence of an occult neurogenic bladder when intending to carry out surgery for patients with severe stress incontinence.

Which factors influenced the result of a tension free vaginal tape operation in a single teaching hospital?

Tension free vaginal tape (TVT) has proven to be successful. Nevertheless, complications of the TVT have been reported. The aim of this study was to describe factors that might influence the efficacy and safety of the TVT procedure in our clinic. Medical records of all patients who underwent TVT surgery between 1 January 2001 and 1 May 2004 were reviewed. To achieve subjective follow-up, in 2004 and 2005, we sent all patients standardised validated questionnaires. Data were analysed with SPSS. A total of 198 TVT procedures were performed. In 75 cases (37.9%), the procedure was combined with vaginal prolapse surgery. Complications were found in 19.7% of all TVT procedures. Most patients (71%) returned the questionnaire. Median follow-up was 27 months (range: 9-49). Subjective success rate was 73%. Logistic regression analysis showed that success rate of the TVT procedure was not influenced by any of the factors we studied. Complications were not more common in patients who had undergone prior incontinence or prolapse surgery. Concomitant prolapse surgery with the TVT, however, was found to be the only risk factor for complications, mainly prolonged catheterisation. In this study, we found no factor that influenced the success rate of the TVT. In the literature, the experience of the surgeon is marked as a factor influencing the success rate. We, therefore, gradually reduced the number of gynecologists who perform TVT. Concomitant prolapse surgery, however, was shown to be an independent risk factor for complications. Therefore, we prefer to 'separate' prolapse and incontinence surgery.

Outcomes Following Repeat Mid Urethral Synthetic Sling After Failure of the Initial Sling Procedure: Rediscovery of the Tension-Free Vaginal Tape Procedure

We evaluated outcomes of the repeat mid urethral sling to treat recurrent or persistent stress urinary incontinence after failure of an initial mid urethral sling. We retrospectively analyzed data on patients who underwent the repeat mid urethral sling procedure due to persistent or recurrent stress urinary incontinence. Repeat slings were placed without removal of the previous sling. All patients were followed at least 1 year after the second mid urethral sling. Of the 31 female patients with a repeat mid urethral sling 29 were followed, including 13 with a retropubic and 16 with a transobturator sling. For the first mid urethral sling 17 patients received a retropubic sling (tension-free vaginal tape) and 12 received a transobturator sling (6 inside out and 6 outside in procedures). Cure and improvement rates irrespective of the approach were 75.9% (22 of 29 patients) and 6.9% (2 of 29), respectively. Cure rates for the retropubic and transobturator slings were 92.3% (12 of 13 patients) and 62.5% (10 of 16), respectively, a difference that did not quite attain statistical significance (p = 0.089). The repeat mid urethral sling for persistent or recurrent stress urinary incontinence has a lower cure rate than the initial sling. However, the retropubic approach tends to have a higher cure rate than the transobturator approach in repeat sling cases.

A multicenter, prospective, randomized clinical trial comparing tension‐free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women

The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity. This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others. The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001). At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.