Retreatment For Stress Urinary Incontinence Research Articles

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair

The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was280. Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval,-0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Three-year Follow-up of a Single Incision Sling Procedure Performed Under Local Anesthesia in an Office Setting

To assess the 3-year success of placing a single-incision midurethral sling (SIMS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. This is a prospective case series of 20 women who underwent in-office SIMS procedure by the DISST from July 2019 to February 2020. This is an extension of our pilot study (11) and all 20 patients were evaluated at a mean follow-up of 34.3months. Success was defined as a composite score of objective success (negative standing cough test at bladder fullness), subjective success based on the modified PGI-I score of "very much better" or "much better," and no retreatment for stress urinary incontinence. Secondary objectives were adverse events, de novo overactivity of the bladder, recurrent urinary tract infections, voiding dysfunction, pain/dyspareunia, and influence on sexual function. The composite success rate was 95% (95% CI [75.1, 99.9]) at the 36-month follow-up. The significant improvement in MESA scores was maintained over the study period. There were no cases of de novo urgency, mesh exposure, postop voiding dysfunction or recurrent urinary tract infections. There were no cases of de novo dyspareunia. SIMS placed by the DISST technique under local anesthesia in an office setting has shown sustained efficacy over a 3-year period with no decrease in cure. Subjects remained dry and reported excellent improvement in symptoms and quality of life at the 36-month follow-up visit.

Cost-effectiveness Analysis: Autologous Rectus Fascial Sling Versus Retropubic Midurethral Sling for Female Stress Urinary Incontinence.

There are limited data on the economic comparison between retropubic midurethral sling and autologous fascial sling. This study aims to evaluate the cost-effectiveness of autologous rectus fascial sling compared with retropubic midurethral sling from both hospital and health care perspectives. A decision tree model was developed with 1 year of follow-up. We included variables such as objective success rate, complications and subsequent treatments, and retreatment for incontinence. The model included the index procedure and 1 retreatment for stress urinary incontinence. Cost estimates were calculated from both hospital and health care perspectives. The outcomes were expressed in incremental cost-effectiveness ratio (ICER) or cost per quality-adjusted life-year (QALY). An ICER <$50,000/QALY was considered cost-effective. From a hospital perspective, the overall cost of retropubic midurethral sling was higher than autologous rectus fascial sling ($2,348.94 vs $2,114.06), but was more effective (0.82 vs 0.80 QALYs). The ICER was $17,452/QALY. From a health care perspective, the overall cost of autologous rectus fascial sling was higher than retropubic midurethral sling ($4,656.63 vs $4,630.47) and was less effective. Retropubic midurethral sling was the dominant strategy, with ICER of -$1,943.32/QALY. If the success rate of autologous rectus fascial sling was ≥84.39%, or the cost of retropubic midurethral sling surgery was > $2,654.36, then autologous rectus fascial sling would become cost-effective. Retropubic midurethral sling is the cost-effective treatment from the hospital perspective and the dominant treatment from the health care perspective. However, changes in the costs and success rates of surgical procedures can alter the cost-effectiveness results.

Outpatient mid-urethral tissue fixation system sling for urodynamic stress urinary incontinence: 3-year surgical and quality of life results

IntroductionTo evaluate the clinical effectiveness and quality of life (QOL) of outpatient mid-urethral tissue fixation system sling (TFS) procedures for urodynamic stress urinary incontinence (SUI) at 3-year follow-up.MethodsWe analyzed 50 mid-urethral TFS sling operations between 2007 and 2012 at Yokohama Motomachi Women’s Clinic LUNA. The primary outcome was success defined as a negative 24-h pad test, negative cough and Valsalva stress test, and no re-treatment for SUI. Secondary outcome was improvement in quality of life, which was assessed using the Incontinence Questionnaire-Short Form (ICIQ-SF) and the Incontinence Impact Questionnaire Short Form (IIQ-7). The 3-year postoperative scores were compared with baseline scores using the Wilcoxon signed rank test. A 5% two-sided significance level was used for all statistical testing.ResultsAll operations were carried out on an outpatient basis with no intraoperative complications. The primary cure rate result at 3-year follow-up was 90%. Median total ICIQ-SF score changed from 12 (6–20) to 0 (0–14) and median total IIQ-7 score changed from 156 (0–300) to 0 (0.00–16.7) at 3-year follow-up.ConclusionsResults show that the TFS mid-urethral sling operation is a simple, safe, effective procedure that may be done without difficulty at a freestanding clinic on an outpatient basis and favorably improves subjective QOL of the patient.

5-Year Longitudinal Followup after Retropubic and Transobturator Mid Urethral Slings

Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.

Pleated colposuspension: Our modification of Burch colposuspension

Introduction:Burch colposuspension is a standard treatment for stress urinary incontinence. However, it is associated with recurrence and urinary retention. We describe a modification of this technique to overcome these problems and evaluate the results in comparison with the standard procedure.Materials and Methods:A total of 145 patients with isolated stress urinary incontinence (SUI), underwent either our modified pleated colposuspension (PC); n = 97) or standard Burch colposuspension (BC) (n = 48). Description of PC: Three No. 0 non-absorbable sutures were placed in the side-to-side manner at the mid-urethral level with 0.5-1.0 cm distance between them using double bites and were passed through the Cooper's ligament. The patients were followed-up every 6 months for SUI and genital prolapse evaluation. Successful surgery was defined as (1) No self-reported SUI symptoms, (2) Negative Marshall's coughing test (MT), (3) No retreatment for SUI, (4) Absence of urodynamic SUI. In addition, failure was defined as the occurrence of urinary retention, use of catheter on 6-week visit, maximum flow rate >15 ml/s, flow time <60 s, or residual urine <100 ml. Data was compared using Student's paired test and Mantel-Haenzel's χ2 test. P > 0.05 was considered significant.Results:The mean follow-up after surgery for PC was 102.4 months and for BC was 103.6 months. At last follow-up, data suggesting failure (Stress score ≥7, urge score ≥7, Pad test with weight < 15 g/day and positive MT during lithotomic/upright position) were more frequent in BC group (P > 0.05; P > 0.0; P > 0.01; P > 0.05; P > 0.05, respectively). The incidence of recurrent SUI was 5.2% after PC and almost triple (14.6%) after BC. Residual urine <100 ml and weak stream were more frequent in the BC group (P > 0.05; P > 0.01, respectively). Detrusor over-activity on urodynamic studies, Flow time <60 s, urethral pressure profilometry positive for obstruction had a higher incidence in BC group (P > 0.01; P > 0.001; P > 0.01, respectively).Conclusion:Our modified pleated colposuspension showed improved outcomes when compared with standard Burch colposuspension.

Treatment Success of Retropubic and Transobturator Mid Urethral Slings at 24 Months

Longer term comparative efficacy information regarding transobturator and retropubic mid urethral slings is needed. We report 24-month continence rates, complications and symptom outcomes from a randomized equivalence trial. Primary outcomes were objective (negative stress test, negative pad test and no re-treatment for stress urinary incontinence) and subjective (no self-report of stress urinary incontinence symptoms, no leakage episodes on 3-day bladder diary and no re-treatment for stress urinary incontinence) success at 24 months. The predetermined equivalence margin was ± 12%. Of 597 randomized participants 516 (86.4%) were assessed. Objective success rates for retropubic and transobturator mid urethral slings were 77.3% and 72.3%, respectively (95% CI for difference of 5.1% was -2.0, 12.1), and subjective success rates were 55.7% and 48.3%, respectively (CI for difference of 7.4% was -0.7, 15.5). Neither objective nor subjective success rates met the prespecified criteria for equivalence. Patient satisfaction (retropubic 86.3% vs transobturator 88.1%, p = 0.58), frequency of de novo urgency incontinence (retropubic 0% vs transobturator 0.3%, p = 0.99) and occurrence of mesh exposure (retropubic 4.4% vs transobturator 2.7%, p = 0.26) were not significantly different. The retropubic mid urethral sling group had higher rates of voiding dysfunction requiring surgery (3.0% vs 0%, p = 0.002) and urinary tract infections (17.1% vs 10.7%, p = 0.025), whereas the transobturator group had more neurological symptoms (9.7% vs 5.4%, p = 0.045). Objective success rates met the criteria for equivalence at 12 months but no longer met these criteria at 24 months. Subjective success rates remained inconclusive for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved. Continued surveillance is important in women undergoing mid urethral sling surgery.

TVT-Secur in Office Sling Procedure Under Local Anesthesia

Our objective was to assess long-term safety, feasibility, and success of performing single-incision mini-sling tension-free vaginal tape (TVT)-Secur (TVT-S) procedure in the office under local anesthesia for stress urinary incontinence. Fifty subjects were enrolled from October 2008 to May 2009. The TVT-S procedure (Hammock approach) was performed per strict guidelines. Success was based on a composite score of 7 subjective and objective measures at 24 months. Success per the composite score was 80%. Retreatment for stress urinary incontinence was 9%. There was significant improvement in quality of life and symptom relief scores (P<0.001). Ninety-four percent were satisfied with the surgical outcome, and 98% felt they made the right decision. There were no intraoperative injuries or complications. Two subjects had mesh exposure in the vagina. In-office single-incision mini-sling TVT-S is safe, feasible, and successful with minimal complications; however, strict criteria need to be followed.

Baseline Urodynamic Predictors of Treatment Failure 1 Year After Mid Urethral Sling Surgery

We determined whether baseline urodynamic study variables predict failure after mid urethral sling surgery. Preoperative urodynamic study variables and postoperative continence status were analyzed in women participating in a randomized trial comparing retropubic to transobturator mid urethral sling. Objective failure was defined by positive standardized stress test, 15 ml or greater on 24-hour pad test, or re-treatment for stress urinary incontinence. Subjective failure criteria were self-reported stress symptoms, leakage on 3-day diary or re-treatment for stress urinary incontinence. Logistic regression was used to assess associations between covariates and failure controlling for treatment group and clinical variables. Receiver operator curves were constructed for relationships between objective failure and measures of urethral function. Objective continence outcomes were available at 12 months for 565 of 597 (95%) women. Treatment failed in 260 women (245 by subjective criteria, 124 by objective criteria). No urodynamic variable was significantly associated with subjective failure on multivariate analysis. Valsalva leak point pressure, maximum urethral closure pressure and urodynamic stress incontinence were the only urodynamic variables consistently associated with objective failure on multivariate analysis. No specific cut point was determined for predicting failure for Valsalva leak point pressure or maximum urethral closure pressure by ROC. The lowest quartile (Valsalva leak point pressure less than 86 cm H2O, maximum urethral closure pressure less than 45 cm H2O) conferred an almost 2-fold increased odds of objective failure regardless of sling route (OR 2.23, 1.20-4.14 for Valsalva leak point pressure and OR 1.88, 1.04-3.41 for maximum urethral closure pressure). Women with a Valsalva leak point pressure or maximum urethral closure pressure in the lowest quartile are nearly 2-fold more likely to experience stress urinary incontinence 1 year after transobturator or retropubic mid urethral sling.

Demographic and Clinical Predictors of Treatment Failure One Year After Midurethral Sling Surgery

To identify clinical and demographic factors predictive of midurethral sling failure. Overall treatment failure was defined by one or more of the following objective outcomes: a positive stress test, positive 24-hour pad test or retreatment for stress urinary incontinence (SUI); subjective outcomes: self reported SUI by the Medical, Epidemiologic and Social Aspect of Aging questionnaire, incontinent episodes by 3-day diary, or retreatment for SUI, or a combination of these. Logistic regression models adjusting for sling type and clinical site were used to predict odds of overall treatment failure after univariable analysis. Models were also fit to compare factors associated with objective failure and subjective failure only. Previous UI surgery (odds ratio [OR] 1.99, 95% confidence interval [CI] 1.14-3.47); maximum Q-tip excursion<30° (OR 1.89, 95% CI 1.16-3.05); Medical, Epidemiologic and Social Aspect of Aging questionnaire urge score per 10 points (OR 1.97, 95% CI 1.21-3.21); and pad weight per 10 g (OR 1.06, 95% CI 1.02-1.10) were predictors of overall failure. Having concomitant surgery (OR 0.44, 95% CI 0.22-0.90) was predictive of subjective failure only rather than objective failure. Age per 10 years (OR 1.48, 95% CI 1.14-1.90); Urogenital Distress Inventory score per 10 points (OR 1.09, 95% CI 1.02-1.17); pad weight per 10 g (OR 1.05, 95% CI 1.01-1.10) were predictive of objective failure compared with subjective failure only. Associations of risk factors and failure were similar independent of sling type (retropubic or transobturator). Twelve months after surgery, risk factors for overall and objective treatment failure were similar in women undergoing retropubic and transobturator sling procedures. This information may assist in counseling patients regarding efficacy of sling procedures and in setting expectations for women at increased odds for treatment failure. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00325039. II.

Urodynamic Measures Do Not Predict Stress Continence Outcomes After Surgery for Stress Urinary Incontinence in Selected Women

We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence. In a 9-center surgical trial, women with stress urinary incontinence were randomized to a Burch or pubovaginal sling procedure. Women were eligible for the study if they had predominant stress urinary incontinence symptoms, a positive cough stress test, a bladder capacity more than 200 ml and urethral hypermobility. Preoperative free uroflowmetry, filling cystometry and pressure flow studies were performed in all. Overall treatment success required a negative pad test, no urinary incontinence on a 3-day diary, a negative stress test, no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence. Stress specific success required all of the last 3 criteria. We examined urodynamic measures, and whether the presence of urodynamic stress incontinence, the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success. Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group, but this trend did not quite reach statistical significance (OR 2.26; 95% C.I. 0.99, 5.17). Odds of stress specific success did not differ by urodynamic stress incontinence status. Subjects with detrusor overactivity did not have significantly worse success rates. Stratifying by treatment group, there was no difference in mean Valsalva leak point pressure values between surgical successes and failures. We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence. The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence. The impact of urodynamic studies on surgical outcomes needs further investigation.

Predictors of Treatment Failure 24 Months After Surgery for Stress Urinary Incontinence

We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence. Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (261) was defined as self-report of stress urinary incontinence by the Medical, Epidemiological, and Social Aspects of Aging questionnaire, positive stress test or re-treatment for stress urinary incontinence. Nonstress failure (66) was defined as positive 24-hour pad test (more than 15 ml) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure. Severity of urge incontinence symptoms (p = 0.041), prolapse stage (p = 0.013), and being postmenopausal without hormone therapy (p = 0.023) were significant predictors for stress failure. Odds of nonstress failure quadrupled for every 10-point increase in Medical, Epidemiological, and Social Aspects of Aging questionnaire urge score (OR 3.93 CI 1.45, 10.65) and decreased more than 2 times for every 10-point increase in stress score (OR 0.36, CI 0.16, 0.84). The associations of risk factors and failure remained similar regardless of surgical group. Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy. Higher urge scores predicted failure by nonstress specific outcomes.