N99.3
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women over 18 years of age Symptomatic vaginal vault prolapse ICS-POPQ Stage II-III Ability to consent Ability to attend the hospital 6 months postoperatively
Exclusion criteria
Exclusion criteria: Gynaecological surgery within the last three months Anticoagulation treatment Participation in another study or non-interventional study History of prolapse surgery with implants/transplants History of pelvic radiotherapy Immunosuppression, chemotherapy at the time of the study Patients requiring another concurrent operation e.g. rectopexy, intestinal resection, colpoperineoplasty, anterior colporrhaphy, paravaginal colpopexy, incontinence surgery Patients with an additional indication for the operative correction of the perineum or concurrent urinary incontinence surgery (concurrent adnexectomy is permitted)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary target figure is the anatomical success. An anatomical surgical success can be assumed when the vaginal apex (point C/ICS-POPQ) does not descend more than 50% of the vaginal length (tvl) on straining. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary target figure is the functional parameter: collection of symptomatic/asymptomatic penetration of suture material in the vagina, the state of health of the patient postoperatively using a Likert scale and the effects of surgery on sexuality using the PISQ-12 questionnaire. Assessment of bladder and bowel function as well as sexuality and prolapse symptoms are performed using the German pelvic floor questionnaire. | — |
Countries
Germany
Contacts
Universtäts-Frauenklinik Tübingen