CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial.

BACKGROUND: Stress urinary incontinence is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, developing effective nonsurgical treatment options would be beneficial. Some studies have suggested that laser therapy may improve or cure stress urinary incontinence. However, there is a lack of sham-controlled randomized controlled trials to judge treatment efficacy. OBJECTIVE: This study aimed to compare the effects of CO2 vaginal laser vs sham therapy for treating stress urinary incontinence. STUDY DESIGN: This was a multicenter, participant-blinded, sham-controlled, parallel group (1:1) superiority randomized controlled trial performed in outpatient clinics in 2 hospitals. We included women aged 18 to 80 years with objective and subjective stress urinary incontinence. Participants had undertaken or declined supervised pelvic floor muscle training. Intervention was performed using a CO2 fractionated vaginal laser. Participants underwent 3 treatments, 4 weeks apart, with increasing energy and density settings. Sham treatment was performed using an identical technique with a deactivated pedal. The primary outcome was the subjective stress urinary incontinence rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective stress urinary incontinence, change in the disease-specific patient-reported outcomes, health-related quality of life, and adverse effects. Categorical outcomes were compared using the chi square test and continuous outcomes using analysis of covariance, adjusting for the baseline score. RESULTS: There were 52 participants who received laser and 49 who received sham treatment. One participant in each group withdrew from the study before the endpoint, and 2 participants in the laser group did not participate in the follow-up visits. Participant mean age was 53 (34-79) years. Mean body mass index was 26.1 (18.1-49.6); 90% were vaginally parous. At 3 months, there was no difference between the sham and active treatment arm in subjective stress urinary incontinence (46 [96%] vs 48 [98%]; relative risk, 0.98 [95% confidence interval, 0.91-1.05]; P=.55) or in objective stress urinary incontinence (37 [80%] vs 33 [80%]; relative risk, 0.99 [95% confidence interval, 0.81-1.23]; P=.995). Patient-reported outcomes and health-related quality of life were also comparable between the groups. Vaginal bleeding occurred in 3 participants after laser and 1 participant after sham treatment. Pain during treatment did not differ between laser and sham treatment. CONCLUSION: We were unable to show an improvement in stress urinary incontinence after CO2 vaginal laser therapy compared with sham treatment.

Efficacy of Clorpactin in refractory bladder pain syndrome/interstitial cystitis: a randomized controlled trial.

INTRODUCTION: Clorpactin is an antibacterial agent with limited evidence for its use as instillation therapy in patients with bladder pain syndrome/interstitial cystitis (BPS/IC). This was a multi-centre, single-blinded randomized controlled trial to investigate whether Clorpactin instillation results in symptom improvement in patients with refractory BPS/IC. METHODS: Fifty women with refractory BPS/IC were randomized to undergo cystoscopy/hydrodistension (25) or instillation of Clorpactin 0.4% solution (25) under general anaesthesia. Primary outcome was based on Global Response Assessment (GRA) at 3 months; secondary outcomes were based on O'Leary Sant Symptom (OLSI) and Problem (OLPI) questionnaire scores, visual analogue scale (VAS) score for pain and bladder diary parameters. RESULTS: Complete follow-up data were available on 22 in the hydrodistension group and 16 in the Clorpactin group. GRA improvement was 4.5% for hydrodistension and 56% for Clorpactin (p = 0.001) at 3 months. Reduction in mean total scores for OLSI (14.1 to 9.1; p = 0.004) and OLPI (12.6 to 7.4; p = 0.001) was seen in the Clorpactin group only. VAS pain scores were reduced in the Clorpactin group only (7.4 to 3.3; p < 0.001). Post-treatment VAS pain scores did not differ between groups although 6/25 (24%) women in the Clorpactin group required admission for pain compared to 1/25 (4%) in the hydrodistension group. CONCLUSIONS: Clorpactin treatment results in significant improvement in BPS/IC symptoms, bother and pain based on the GRA, OLSI/OLPI and VAS pain scores at 3 months post-treatment compared to cystoscopy/hydrodistension. These conclusions are limited by the high loss to follow-up in both groups.

TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.

INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically. RESULTS: Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status. CONCLUSION: We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.

RCT of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior mesh versus sacrocolpopexy: 4-year outcome.

INTRODUCTION AND HYPOTHESIS: This study assessed the safety and efficacy of vaginal extraperitoneal uterosacral ligament suspension (VEULS) with anterior overlay mesh versus sacrocolpopexy (SCP) for posthysterectomy vault prolapse. METHODS: This was a multicenter randomized trial of women with posthysterectomy vault prolapse stage >2 according to the Pelvic Organ Prolapse Quantification (POP-Q) system. Primary outcome was a composite of no vaginal bulge symptoms, no anatomical recurrence in the anterior or apical compartment at or beyond the hymenal ring, and no surgical retreatment for prolapse 12 months postsurgery. Secondary outcomes were peri- and postoperative complications, changes in prolapse, and urogenital and sexual symptoms at 12, 24, and 48 months based on the Pelvic Floor Distress Inventory (PFDI)-20. RESULTS: Between 2006 and 2011, 82 eligible women were randomized: 39 received VEULS and 43 received SCP. Primary composite outcome at 12 months for success was 41% for VEULS and 65% for SCP [odds ratio (OR 2.68, p = 0.03)]. Perioperative complications were more common in the SCP group. C-point was higher for SCP (-6.0 VEULS vs -8.0 SCP, p = 0.005) and total vaginal length (TVL) was longer for SCP (8.0 VEULS vs 9.0 SCP, p = 0.05). Cumulative mesh exposure rate at 4 years was similar between the uterosacral [4/39 (10.3%)] and sacrocolpopexy [4/43 (9.3%)] groups, bearing in mind that not all patients were examined at 4 years. Subjective outcomes derived from three domains of the PFDI-20 were similar at 12, 24, 48 months. Postoperative Pelvic Organ Prolapse Distress Inventory (POPDI) score improved similarly for both groups at all timepoints, with the minimally important difference of at least 21 reached for both groups. CONCLUSIONS: Composite outcome of success was better for SCP at 12 months, but subjective outcomes for prolapse at all timepoints over 4 years for VEULS and SCP were not significantly different.