se of absorbable versus non-absorbable sutures for vaginal implant fixation during sacrocolpopexy as part of the surgical treatment of vaginal vault prolapse ICS-POPQ stage II-III

Not Applicable

• Conditions: N99.3; N94.1; Prolapse of vaginal vault after hysterectomy; Dyspareunia

• Registration Number: DRKS00003263
• Lead Sponsor: niversitäts-Frauenklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-14
• Study Completion: 2016-07-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 208

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.