N81.1 R39.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate is defined anatomically, primary endpoint is the number of women with anatomical success 1-2 years after surgery. 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
| Measure | Time frame |
|---|---|
| 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. Development of quality of life 1-2 years after surgery (postoperative satisfaction based on the Likert scale). | — |
Countries
Germany
Contacts
Deutsches Beckenbodenzentrum, Klinik für Urogynäkologie, St. Hedwig-Krankenhaus