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.

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.

Native tissue repair or transvaginal mesh for recurrent vaginal prolapse: what are the long-term outcomes?

INTRODUCTION AND HYPOTHESIS: The objective of this study was to assess outcomes in native tissue (NT) and transvaginal mesh (TVM) repair in women with recurrent prolapse. METHODS: A retrospective two-group observational study of 237 women who underwent prolapse repair after failed NT repair in two tertiary hospitals. A primary outcome of "success" was defined using a composite outcome of no vaginal bulge symptoms, no anatomical recurrence in the same compartment beyond the hymen (0 cm on POPQ) and no surgical re-treatment for prolapse in the same compartment. Secondary outcomes assessed included re-operation for prolapse in the same compartment, dyspareunia and mesh-related complications. RESULTS: Of a total of 336 repairs, 196 were performed in the anterior compartment and 140 in the posterior compartment. Compared with the TVM groups, women undergoing repeat NT repair were more likely to experience anatomical recurrence (anterior 40.9 % vs 25 %, p = 0.02, posterior 25.3 % vs 7.5 %, p = 0.01), report vaginal bulge (anterior 34.1 % vs 12 %, p < 0.01, posterior 24.1 % vs 7.5 %, p 0.02) and had a higher prolapse re-operation rate (anterior 23.9 % vs 7.4 %, p < 0.01, posterior 19.5 % vs 7.5 %, p = 0.08). Using composite outcomes, the success rate was higher with TVM repair in both compartments (anterior 34.2 % vs 13.6 %, p <0.01, posterior 56.6 % vs 23.0 %, p <0.01). Re-operations for mesh exposure were 9.3 % anteriorly and 15.1 % posteriorly. Although the number of women requiring a prolapse re-operation is lower in the TVM group, the overall re-operation rate was not significantly different when procedures to correct mesh complications were included. CONCLUSIONS: Although the success rate is better with the use of TVM for recurrent prolapse, the total re-operation rates are similar when mesh complication-related surgeries are included.

Should Genital Hiatus/Perineal Body Be Measured at Rest or on Valsalva?

OBJECTIVE: Genital hiatus (Gh) and perineal body (Pb) are part of the Pelvic Organ Prolapse Quantification assessment system, but it is unclear whether measurements should be taken at rest or on Valsalva. This study was designed to assess the predictive value of Gh and Pb measurements obtained at rest and on Valsalva for signs and symptoms of pelvic organ prolapse (POP). METHODS: This is a retrospective study involving 416 women who presented to a tertiary urogynecology unit with symptoms of pelvic floor dysfunction. Genital hiatus and Pb were measured at rest and on maximal Valsalva. The strength of association between binary markers of POP and measurements of Gh/Pb was estimated using logistic regression analysis. Receiver operator characteristic statistics were used to compare predictive values of Gh and Pb measurements obtained at rest and on Valsalva. RESULTS: A total of 451 women were seen during the study period. Thirty-five were excluded owing to missing data, leaving 416. Fifty-four percent (n = 223) complained of POP symptoms. On examination, 80% (n = 332) had significant POP (stage 2+ in anterior or posterior compartments or stage 1+ in the central compartment). On imaging, significant POP was diagnosed in 66% (n = 275). Mean hiatal area was 22 cm (SD, 7; range, 5-49 cm) at rest and 30 cm (SD, 10; range, 11-69 cm) on Valsalva. Genital hiatus and Pb measured on Valsalva were consistently stronger predictors of prolapse symptoms and objective prolapse (by clinician examination and by ultrasound) than at Gh and Pb measured at rest. The corresponding area under the curve values were significantly larger for Gh/Pb measures on Valsalva after adjusting for multiple confounders. CONCLUSIONS: Genital hiatus/Pb measured on maximal Valsalva is a superior predictor of symptoms and signs of POP compared with Gh/Pb at rest.