Study To Assess Whether Polypropylene Mesh In Surgery For Cystocele Is Safe And Has Favorable Outcome
Not Applicable
- Conditions
- Pelvic Organ Prolapse, Related Complications To The Use Of Polypropylene Mesh in Vaginal Surgeries, Urinary Incontinence, Lower urinary tract symptomsC23.888.942.343
- Registration Number
- RBR-7m2xdy
- Lead Sponsor
- niversidade Federal de São Carlos
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Not pregnant women; signs and symptoms of genital prolapse; no acute urinary or vaginal infection; no malignant disease; sign in the informed consent
Exclusion Criteria
previous surgery for pelvic organ prolapse with polipropylene mesh interposition; mentally disable; ot sign on the informed consent
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best anatomical results of anterior vaginal wall prolapse of the patients in the intervention group compared with the control group 12 and 24 months after surgery, analyzed by the method Pelvic Organ Prolapse Quantification System (POP-Q). It is expected anatomic failure at 12 months follow-up of 38% for the control group and 12% for the intervention group. To detect this difference (two-sided test), with significance level of 0.05 and a test power of 80%, 42 women should be allocated at least in each group.
- Secondary Outcome Measures
Name Time Method Resolution rate of lower urinary tract symptoms (urinary incontinence, voiding difficulty, urgency and urge incontinence) at least similar between the intervention and control groups 12 and 24 months after surgery, assessed by means of questionnaires International Consultation on incontinence Questionnaire Urinary incontinence Short Form (ICIQ-UI SF) and Overactive Bladder Questionnaire (OAB-V8), both validated for the Portuguese language.<br>