Patients and methods
incontinence, prolapse, Continence, PVS, stress failure
RECURRENCE, STRESS INCONTINENCE, INCONTINENCE, PROLAPSE, PAD, SECONDARY, LEAKAGE, STRESS INCONTINENCE
This is a prospective randomized trial. Patients underwent a stress test that is positive if leakage was observed while the patient coughed in the lithotomy position with the bladder 200 ml full. POP was staged according to the POP Quantification (POPQ) [Urodynamic testing was performed and included filling and voiding cystometry. Medium fill water cystometry (50 ml/min) using a dual lumen 8 Fr catheter was performed. The technique, definitions, and units conformed to the standards proposed by the International Continence Society [Stress incontinence was defined as involuntary leakage upon effort or exertion [Written informed consent was obtained from the women enrolled, and IRB approval was obtained from the urology department (Approval # 2017_009).Patients were randomized using closed envelopes. The type of anti-incontinence procedure was left to the surgeon’s discretion. For PVS, a technique similar to that previously described [The primary outcome was the cure of POP as indicated by local examination. The secondary outcome measure was cure of incontinence as indicated by negative stress and 1-h pad tests. Treatment failure was defined as recurrence of stress incontinence, as demonstrated by the positive stress test or positive pad test (stress failure) or recurrence of the same stage of prolapse upon local examination.Statistical analysis was conducted using SPSS version 22. Continuous normal data were compared using Student’s The statistical power of the study was calculated considering the success rate of 50% in any arm, an alpha error of 0.05 with a 1:1 enrollment ratio and a power of 80%. The calculated sample size was 116 and the margin of error was 5.94% (there was a 80% chance that the real value was within ± 5.94% of the measured value).Figure Consolidated Standards of Reporting Trials flow chart of the study