Defining success after surgical treatment of stress urinary incontinence.

BACKGROUND: A consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. OBJECTIVE: This study aimed to identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified "more accurate" treatment success definitions with a commonly used composite definition of success (ie, no reported urine leakage, negative cough stress test result, and no retreatment). STUDY DESIGN: We evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of participant-assessed symptom improvement and participant-assessed surgical success scores with an 11-point Likert scale among those achieving success and failure. The "more accurate" treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges g values. The treatment success definitions with the highest Hedges g values were considered "more accurate" treatment success definitions and were then compared with the composite definition of success. RESULTS: The percentage of participants who had treatment success (6.4% to 97.3%) and Hedges g values (-4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ≤5, Urogenital Distress Inventory-6 score ≤33.3, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges g values and were considered the top 3 "more accurate" treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate between participant-assessed symptom improvement and surgical success. When the "more accurate" treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores and a higher proportion of survey responses indicating complete satisfaction or some level of satisfaction and very good/perfect bladder condition. In addition, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 "more accurate" treatment success definitions. CONCLUSION: Successful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used. However, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The "more accurate" treatment success definitions better differentiated between participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionately misidentified participants who reported minor symptoms or complete/partial satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 "more accurate" treatment success definitions.

A nationwide cohort study of hospital contacts after surgical treatment for urinary incontinence.

AIMS: The aim was to assess complications of urinary incontinence (UI) for women who had a hospital contact within 30 days and to evaluate the conventional method of classifying complications vs grading complications into the Clavien-Dindo classification (CDC) system. METHODS: A historical cohort study based on a nationwide population of women who had hospital contact within 30 days of surgical treatment for UI during a 5-year period. RESULTS: There were 874 (16.2%) hospital contacts to the Department of Obstetrics and Gynecology, among 5393 procedures. For retropubic midurethral sling (RPMUS) and transobturator midurethral sling (TOMUS), the most common reasons for hospital contacts were voiding dysfunction, self-reported pain within 14 days and acute cystitis and for urethral injection therapy (UIT) persisting UI, acute cystitis, and voiding dysfunction. Voiding dysfunction requiring surgery, use of catheter or both, occurred more frequently in women who had RPMUS as compared with TOMUS (30.5% vs 21.7%; P = .01). Women, who received RPMUS and TOMUS, had surgical complications classified as up to CD IIIb, whereas women who had UIT were classified as up to CD II. CONCLUSIONS: Sixteen percent of the women had a hospital contact within 30 days. A more obstructive character of RPMUS than for TOMUS was indicated, as more women with voiding dysfunction required surgery or catheter following RPMUS. The CDC system in its current form does not improve the overall characterization of complications in terms of type and severity following synthetic midurethral sling and UIT treatment.

Comparing postoperative voiding dysfunction after mid-urethral sling using either a Babcock or Kelly clamp tensioning technique.

INTRODUCTION AND HYPOTHESIS: The objective was to compare postoperative urinary retention using the Babcock and Kelly clamps for retropubic midurethral sling (RPS) tensioning. METHODS: This was a retrospective cohort of isolated RPS procedures from December 2010 through April 2016 by five fellowship-trained surgeons at two institutions. Slings were tensioned with a Babcock clamp by grasping a 3-mm midline fold of mesh (RPS-B) or a Kelly clamp as a spacer between the sling and suburethral tissue (RPS-K). Assessment of urinary retention included the primary outcome of postoperative catheterization and several secondary outcomes, including discharge home with a catheter, within 1 year of surgery. Analysis of covariance was used to compute the mean difference in duration of catheterization and log-binomial regression was used to calculate risk ratios (RR) and 95% confidence intervals (CI). RESULTS: We included 240 patients. The RPS-B group had a lower body mass index and was more likely to be menopausal, have had pelvic organ prolapse surgery, and have a lower maximum urethral closure pressure than the RPS-K group. The mean duration of catheterization was similar, as demonstrated by the crude (0.21 days [-0.30-0.71]) and BMI-adjusted (0.07 days [-0.41-0.55]) mean difference in duration of catheterization. The incidence of postoperative OAB symptoms was comparable between the groups (BMI-adjusted RR: 0.95 (0.80-1.1)), and the incidence of revision did not differ (p = 0.7). CONCLUSIONS: The Babcock and Kelly clamp tensioning techniques appear comparable, with a low incidence of prolonged postoperative catheterization. Most catheters were removed on the day of the surgery. It is reasonable to tension retropubic midurethral slings with either method.

A Danish national population-based cohort study of synthetic midurethral slings, 2007-2011.

INTRODUCTION AND HYPOTHESIS: Synthetic midurethral slings (MUSs) have shown similar cure rates in several short- and medium-term follow-up studies. Recently, long-term follow-up studies have indicated that the cure rate is higher following the retropubic midurethral sling (RPMUS) compared with the transobturator midurethral sling (TOMUS) procedure. The aim was to evaluate the efficacy of synthetic MUSs and to examine the influence of department and surgeon volume and patient-related factors on the cure rate of synthetic MUSs. METHODS: A retrospective cohort study based on a national population over a 5-year period (2007-2011) using data from the Danish Urogynaecological Database (DugaBase). RESULTS: A total of 4519 women with first-time MUS were registered in the DugaBase. Cure was achieved in 1242/1639 (75.78%) at a 3-month follow-up. RPMUSs were more frequently in use in high-volume departments compared with the other departments and more often implanted by high- than low-volume surgeons. Women treated by a medium- (adjusted OR 1.82; 95% CI 1.01-3.28, "frequency") or high-volume surgeon (1.98; 1.18-3.32, "frequency") had an increased probability of cure compared with women treated by a low-volume surgeon. The difference was only significant for women who received a TOMUS. CONCLUSIONS: This national population-based cohort study confirmed a high cure rate of synthetic MUSs at short-term follow-up. It is the largest study to indicate a learning curve for TOMUS. Patients were not actively involved in which synthetic MUS was to be performed as the choice of surgical option was made at the departmental level.

Bladder injury and success rates following retropubic mid-urethral sling: TVT EXACT™ vs. TVT™.

OBJECTIVE: Although placement of a retropubic mid-urethral slings (MUS) is one of the gold standard surgical treatments for stress urinary incontinence, new devices are poorly evaluated before marketing. We compared TVT-EXACT™ (TVT-E), a new device expected to reduce bladder injuries, with the historically described bottom-to-top TVT™ (TVT). STUDY DESIGN: This retrospective study compared TVT-E (n=49) and TVT (n=49). The main outcomes were the prevalence of complications (bladder injuries, immediate postoperative pain, perioperative complications, etc.) and the short-term success rate (no reported urinary leakage and negative cough test) of both MUSs. RESULTS: Minimum follow-up was 12 months. The characteristics of the two groups were comparable. The prevalence of bladder injury for TVT-E and TVT was 8% and 6%, respectively (p=1). The intensity of immediate postoperative pain (VAS/100) was lower following TVT-E than after TVT (8.0 vs. 15.9, p=0.01). The first post-void residual was increased in the TVT-E group (153.9 vs. 78.9mL, p=0.045), and there were more postoperative bladder outlet obstruction (BOO) symptoms in the TVT-E group (24% vs. 6%, p=0.02). However, there was no difference when considering only de novo BOO (14% vs. 4%, p=0.16). The prevalence of peri- and post-operative complications was equal in the two groups. The success rate was similar at 12 months of follow-up (80 vs. 82%, p=1). CONCLUSION: The prevalence of bladder injury was unchanged with TVT-EXACT™ compared with TVT™, but post-operative pain was decreased. The success rate of both retropubic MUSs was similar at 12 months of follow-up.

Análisis comparativo entre la colocación medio-uretral de malla sintética (cinta vaginal sin tensión [TVT] y cinta a través del músculo obturador [TOT]); en el tratamiento quirúrgico de la incontinencia urinaria de esfuerzo en mujeres en un período de tiempo de 3 años (2009-2012) / Comparative analysis between the mid-urethral synthetic tape (tension-free vaginal tape [TVT] and transobturator tape [TOT]); in the surgical treatment of stress incontinence in women in a three-year period (2009 ­ 2012)

Introducción: la incontinencia urinaria de esfuerzo es la pérdida involuntaria de orina debido al aumento de presión intra- abdominal. El abordaje vaginal por cinta mediouretral es actualmente el método quirúrgico de elección para el tratamiento de IUE con las técnicas: cinta vaginal sin tensión (TVT) y cinta a través del músculo obturador (TOT). Objetivo: determinar la eficacia y complicaciones observadas after the placement of synthetic midurethral sling for the surgical treatment of urinary incontinence in a period of 3 years at HCAM. posterior a la colocación mediouretral de malla sintética TVT y TOT en el tratamiento quirúrgico de la incontinencia urinaria de esfuerzo en un período de 3 años en el HCAM. Materiales y métodos: se realizó un análisis retrospectivo en pacientes que fueron sometidas a cirugía con la colocación de malla mediouretral para IUE en el HCAM. 218 pacientes fueron estudiados, se registraron datos clínico-demográficos, perioperatorios, transoperatorios, y del seguimiento postoperatorio incluidas complicaciones y mejoría clínica de la IU para evaluar la eficacia y seguridad de los métodos. TVT en la apreciación subjetiva y objetiva de la mejoría clínica (87% vs 82% y 92% vs 90% respectivamente). La perforación vesical se presentó en el 14% en el grupo TVT vs 0.5% del grupo TOT. Complicaciones graves que llevaron a reoperación se presentaron mayoritariamente en el grupo TVT (4.8% vs 2.25% / p= 0.356). Conclusiones: comparativamente, ambas técnicas mostraron similar eficacia a través del tiempo de estudio. Sin embargo TOT tendría menos complicaciones, especialmente en referencia a la perforación vesical. Además, TVT requirió mayor tiempo operatorio, estancia hospitalaria.

Introduction: stress urinary incontinence is the involuntary loss of urine due to increased intra-abdominal pressure. The vaginal approach using midurethral slings is now the most common surgical method for the treatment of SUI with two main techniques: tension free vaginal sling [TVT] and transobturator midurethral sling [TOT]. Objective: to determine the efficacy and complications observed after the placement of synthetic midurethral sling for the surgical treatment of urinary incontinence in a period of 3 years at HCAM. Materials and methods: a retrospective analysis was performed in patients who underwent surgery with placement of midurethral sling for the surgical treatment of SUI at HCAM. 218 patients were studied; clinical-demographics, perioperative, intraoperative, and postoperative complications including monitoring data and clinical improvement of SUI were recorded to assess the efficacy and safety of methods. Results: the TOT group prevailed in effectiveness with no statistically significant difference with respect to the TVT group in assessing subjective and objective clinical improvement (87% vs 82 % and 92 % vs 90 % respectively). Bladder perforation occurred in 14% in the TVT group vs. 0.5 % of the TOT group. Severe complications leading to re operation were mainly presented in the TVT group (4.8 % vs 2.25 % / p=0.356). Conclusions: comparatively, both techniques showed similar efficacy over time of study. However TOT would have fewer complications, bladder perforation being the most important. In addition, TVT required longer operative time, hospital stay.