Investigation after vaginal cystocele repair with double-layered fascia plication and hysterectomy for prolapse
- Conditions
- N81.1R39.1CystoceleOther difficulties with micturition
- Registration Number
- DRKS00021807
- Lead Sponsor
- Deutsches Beckenbodenzentrum, Klinik für Urogynäkologie, St. Hedwig-Krankenhaus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Double-layered vaginal cystocele repair and vaginal hysterectomy for prolapse in the period 01/2018 to 12 months before examination
-patients of the DBBZ over the age of 18
-ability to informed consent
-Willing and able to join follow-up visit and complete a questionnaire
Exclusion Criteria
-Previous pelvic floor repair
-concomitant surgery such as posterior vaginal wall repair, perineal body reconstruction, incontinence procedures (not excluded are simultaneous interventions such as biopsy samples, cyst extirpation, adnectomy, adhesiolysis)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rate is defined anatomically, primary endpoint is the number of women with anatomical success 1-2 years after surgery.<br><br>Anatomical success is evaluated using the ICS-POPQ system for objective assessment. A success can be assumed if the anterior vaginal wall and the vaginal apex (point Aa, Ba and C in the ICS-POPQ system) are more than 1 cm proximal of the hymen (stage 0 and I according to POPQ).
- Secondary Outcome Measures
Name Time Method Percentage of women with improvement in bladder emptying (postvoidal residual) 1-2 years after surgery compared to before surgery. In case of sonographic postvoidal residual it is measured by single-use catheter.<br><br>Development of quality of life 1-2 years after surgery (postoperative satisfaction based on the Likert scale).