Transobturator Tape: Over 10 Years Follow-up.

OBJECTIVES: To assess subjective and objective outcomes in incontinent patients following "out-in" TOT, at >10-year follow-up; to evaluate effect on quality of life and other urinary symptoms, late adverse events and predictive factors for failure. METHODS: This single-centre prospective study evaluated women with "complicated" or "uncomplicated" stress urinary incontinence (SUI) following "out-i"' TOT between 2003 and 2007. The pre-op work-up comprised: history; pelvic examination; cough stress test; urodynamic study; UDI-6; and King's Health questionnaires. Work-up was the same as pre-op plus the Patient Global Impression of Improvement scale with final follow-up in 2017. RESULTS: One hundred thirty six consecutive patients underwent TOT; at final follow-up (mean 145 months) we evaluated 123. Cure rates: objective: 78.9%; subjective: 62.6%; no significant deterioration in SUI cure rates over time. Urgency and urgency urinary incontinence (UUI) significantly reduced. Voiding dysfunction increased without urodynamic obstruction. De novo urgency appeared in 7.3% and de novo UUI in 4.1%. In the 31 uncomplicated SUI patients, the objective cure rate was 87.1% and the subjective cure rate was 72.2%. De novo urgency appeared in 9.7% and de novo UUI in 3.2%. Nine King's Health questionnaires domains saw statistically significant improvements. In univariate analysis, pre-op wet OAB was associated with subjective recurrent SUI (P < .038) and parity >2 was associated with objective recurrent SUI (P = .023). We had 5 cases of partial mesh exposure. CONCLUSION: Cure rates are satisfactory, 10 years after TOT surgery, with good quality of life and few major complications. However, some postoperative symptoms may be caused by long-term treatment failure or by advancing age or another pathology.

Transobturator mid-urethral sling in females with stress urinary incontinence and detrusor underactivity: effect on voiding phase.

INTRODUCTION AND HYPOTHESIS: To assess whether detrusor underactivity (DU) is a risk factor for voiding dysfunction (VD) after transobturator tape (TOT) and if a detrusor pressure at maximum flow (PdetQmax) value predicts postoperative VD in DU patients. Also, we examined uncomplicated patients for postoperative VD. METHODS: This is a prospective long-term study on SUI patients who underwent TOT. Exclusion criteria were preoperative POP stage ≥ 2, previous anti-incontinence surgery and comorbidities. Patients were grouped by detrusor contractility using the projected isovolumetric pressure (PIP) index (PdetQmax + maximum flow rate) with values of 30-75 cmH2O indicating normal contractility. Follow-up was at 1, 3, 6 and 12 months, and then annually. All patients underwent a stress test and responded to the Urogenital Distress Inventory questionnaire and to the King's Health Questionnaire. The subjective cure was evaluated using the Patient Global Impression of Improvement. We determined the diagnostic accuracy of PdetQmax levels using ROC curve analysis, with a cut-off point calculated for optimal sensitivity and specificity. RESULTS: In 2007-2013, 118 patients underwent TOT. We included 50 in the undercontractility group (G1) and 50 in the normocontractility group (G2). Continence rates were 82% in G1 and 84% in G2 (mean follow-up 76 months). VD increased from 18 to 36% (p < 0.05) in G1 and from 14 to 16% (p = 0.198) in G2. De novo VD was 28% in G1 and 2% in G2. In the G1 group PdetQmax ≤ 12 cmH2O predicted postoperative VD with 71.4% specificity and 80.0% sensitivity. CONCLUSIONS: DU adversely affects the voiding phase of micturition after TOT. In DU patients, PdetQmax ≤ 12 cmH2O predicts postoperative VD.

Mixed urinary incontinence: A prospective study on the effect of trans-obturator mid-urethral sling.

OBJECTIVES: It is hypothesized that urethral dysfunction is central in mixed urinary incontinence (MUI) in women, since urine entering the proximal urethra under increased intra-abdominal pressure provokes a urethro-detrusorial reflex and involuntary detrusor contraction. Mid-urethral slings have been proposed as a solution. Our primary objective was to evaluate the long-term subjective and objective outcomes on continence and other urinary symptoms of a trans-obturator mid-urethral sling (TOT) procedure. Our secondary objectives were to determine its impact on quality of life (QoL), and to investigate which factors influence outcomes. STUDY DESIGN: This is a single-centre prospective study on a consecutive series of 86 women who underwent TOT for MUI as defined by ICS/IUGA. Since the definition of MUI that we used is symptom-based, we included patients both with and without associated detrusor overactivity. All patients underwent placement of Monarc® Subfascial Hammocks. STATISTICAL ANALYSIS: We used the McNemar chi-square test, the paired t-test and Fisher's exact test. A logistic regression model and odds ratios were used to assess age, parity, body mass index, menopausal status, preoperative detrusor over-activity, and detrusor pressure at maximum flow as possible factors for treatment failure. Only those that were statistically significant in the univariate analysis were included in the multivariate analysis. RESULTS: With a mean follow-up of 59 months, SUI was cured objectively in 83.7% of patients and subjectively in 87.2%. Three patients underwent further anti-incontinence surgery. The continence rates were 74.4% for urgency urinary incontinence (UUI) and 66.3% for SUI-UUI. The patient-reported success rate was 87.2% ('much better' or 'very much better' on Patient Global Impression of Improvement scale). There were statistically significant improvements in all domains except general health. The univariate analysis found no significant risk factor for persistence of SUI. Median age >60 years and menopause were predictive for persistence of UUI. Median and mean age >60 years were predictive of persistence of overall incontinence. In the multivariate model, all variables lost their statistical significance. CONCLUSION: Our study demonstrates TOT surgery can be performed for patients with MUI following unsuccessful conservative therapy. We also demonstrate that menopause and age >60 are risk factors for failure. This should be considered when counselling preoperatively.

Single incision sling (Ajust™) for the treatment of female stress urinary incontinence: 2-year follow-up.

OBJECTIVE: The primary outcome of this study was to evaluate the subjective and objective outcomes of an adjustable Single Incision Sling (Ajust™ C.R. Bard Inc., New Providence, NJ, USA) for the treatment of SUI, with a 2-year follow-up. The secondary outcome was to evaluate the safety of this procedure and the impact of this mini-sling on the filling and voiding phases of the bladder. STUDY DESIGN: In our prospective multicenter study we included 95 females with a clinical symptomatic and urodynamic diagnosis of primary SUI, and unsuccessful previous conservative treatment. Cure rate was evaluated objectively, using a standardized cough stress test and subjectively using the patient global impression of improvement. The King's Health questionnaire was used to evaluate quality of life (QoL). Urgency was evaluated using the patient perception of intensity of urgency scale. Complications were assessed intra-, peri- and post-operatively. All patients underwent urodynamic studies pre-operatively and at 6 months. The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Fisher exact test for continuous non-parametric variables. A logistic regression model and odds ratios (with 95 percent confidence intervals) were used to assess the independent prognostic value of four variables for the outcome (age, parity, body mass index and menopausal status). RESULTS: 92 Patients completed the 2-year follow-up. The objective cure rate was 83.7% and the subjective cure rate was 81.5%. De novo urgency was present in 9 patients (9.8%) and was associated with de novo urge incontinence in 6 patients (6.5%). Only 1 patient with de novo urge incontinence showed de novo detrusor overactivity. Regarding QoL, the King's Health Questionnaire indicated a statistically significant improvement in all domains except sleep. We observed no intraoperative complications. Post-operatively 1 patient referred pain in the right leg, 3 patients had mesh extrusions, 1 patient had recurrent urinary tract infections. Post-operative urodynamics showed a statistically significant increase of detrusor pressure at maximum flow and a reduction of maximum flow rate. No patients were obstructed according to the Blaivas and Groutz nomogram.

Collagen-coated polypropylene mesh in vaginal prolapse surgery: an observational study.

OBJECTIVE: We evaluated the efficacy and safety of a collagen-coated polypropylene mesh with a trans-obturator approach for cystocele repair. STUDY DESIGN: We considered as eligible for our study 97 patients with a stage ≥ 2 cystocele according to the Pelvic Organ Prolapse Staging System (POP-Q), with or without associated apical or posterior vaginal wall prolapse. They were also evaluated pre- and post-operatively using validated questionnaires (P-QoL, Wexner and PISQ-12). Patients underwent cystocele repair using Avaulta Biosynthetic Anterior Support System (CR Bard Inc., Billerica, USA). Objective anatomical cure was defined when points Ba, C and Bp were at stage 0 (good outcome) or stage 1 (satisfactory outcome). The McNemar chi-square test was used to compare categorical variables, the paired t-test for continuous parametric variables, and the Mann-Whitney test for continuous non-parametric variables. RESULTS: All patients completed the 1-year follow-up. We observed an anatomical cure rate of 64.9% for anterior vaginal wall prolapse (point Ba<-1), and a statistically significant improvement in storage, voiding, post-micturition and prolapse-related symptoms. Quality of Life and sexuality were also statistically improved, while we found no impact on anorectal function. We also observed the development of vaginal mesh exposure in 21 patients (21.6%). CONCLUSION: Our data suggest that the collagen-coated polypropylene mesh, as we used it, gives a high recurrence rate (35.1%) and a high exposure rate (21.6%) at one-year follow-up, and is consequently unsatisfactory for the treatment of anterior vaginal wall prolapse.

High levator myorraphy versus uterosacral ligament suspension for vaginal vault fixation: a prospective, randomized study.

INTRODUCTION AND HYPOTHESIS: Our study compared high levator myorrhaphy (HLM) and uterosacral ligament suspension (USLS) for vaginal apex fixation from both an anatomical and functional point of view, and assessed the impact of surgery on quality of life (QoL) and sexuality. METHODS: Two hundred twenty-nine patients with symptomatic stage >or=2 apical prolapse were randomized to USLS or HLM. Those patients who also needed cystocele repair additionally underwent an anterior prosthetic reinforcement. We defined as cure no prolapse of stage 2 or greater in any compartments according to the POP-Q system. RESULTS: Correction of apical prolapse was observed in 96.6% of the HLM group and 98.3% of the USLS group. However, a persistent anterior wall prolapse occurred in 29.2% of the HLM group and in 35.4% of the USLS group. Both groups reported improvement in storage, voiding, and prolapse-related symptoms. Urodynamics of patients in the HLM group showed post-operative reduction in detrusor pressure at maximum flow and an increase in maximum flow. Both groups saw similar improvement in QoL. We did not encounter any serious side effects, except for nine cases of intraoperative ureteral occlusion following USLS. CONCLUSION: This study demonstrates similar efficacy of HLM and USLS for vaginal apex suspension; however, USLS has a higher incidence of complications involving the upper urinary tract.

High levator myorrhaphy for transvaginal suspension of the vaginal apex: long-term results.

PURPOSE: We evaluated the long-term outcome and complications of high levator myorrhaphy for vaginal apical defects. MATERIALS AND METHODS: A total of 286 patients underwent high levator myorrhaphy. Patients underwent preoperative and postoperative urogynecologic assessment, including evaluation of prolapse stage according to the international pelvic organ prolapse staging system and conventional urodynamic testing. Quality of life was evaluated using the prolapse quality of life questionnaire. We considered failure as vaginal prolapse stage 2 or greater according to the pelvic organ prolapse staging system. RESULTS: A total of 272 patients with a mean age of 60.4 years were available for analysis. Mean followup was 5 years. In 247 patients we associated tension-free cystocele repair with Marlex mesh. In 50.7% of patients high levator myorrhaphy was done with curative intent, while in the remaining 49.3% it was a preventive measure. Complications included a rectal tear in 2 cases, Marlex mesh erosion in 23 (8.4%), vaginal vault abscess in 1, pararectal hematoma in 2 and buttock pain in 2. Anatomical evaluation at followup revealed a 96.7% cure rate for apical defects and a 26.8% incidence of cystocele. We observed improvement in filling, voiding and post-void symptoms. Quality of life evaluation showed improvement in all domains. We detected a 9.6% incidence of de novo dyspareunia. CONCLUSIONS: High levator myorrhaphy is a safe and effective procedure for preventing and curing vaginal apical defects. The simplicity of this surgical procedure, its short learning curve, the lack of severe complications and its low costs combined with symptomatic relief and improvement in quality of life encourage its use for the cure and routine prevention of vaginal apical prolapse.