onabsorbable versus Absorbable Sutures for Anterior Colporrhaphy
Not Applicable
Recruiting
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0006334
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 192
Inclusion Criteria
*Anterior vaginal descent beyond the hymen (i.e. POPQ Ba>0)
*Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)
Exclusion Criteria
*Recurrent anterior vaginal wall prolapse
*Reconstructive surgery using mesh or obliterative surgery for prolapse is planned
*Known pelvic malignancy
*Systemic glucocorticoid or immunosuppressant treatment
*Subject wishes to retain her uterus
*Subject is unable and unwilling to participate in
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surgical success: defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen (POPQ point Ba>0); (2) presence of vaginal bulge symptoms (affirmative response to the question 3 from the Pelvic Floor Distress Inventory-20 (do you usually have a bulge or something falling out that you can see or feel in your vaginal area?; (3) re-treatment for recurrent anterior vaginal wall prolapse by either surgery or pessary.
- Secondary Outcome Measures
Name Time Method Change of POPQ values and PFDI-20 scores, The rate of adverse events related with anterior colporrhaphy