Feasibility study for a randomised controlled trial evaluating the use of absorbable mesh, polydioxanone and polyglactin sutures for anterior and posterior vaginal wall prolapse repairs

Completed

• Conditions: Prolapse; Urological and Genital Diseases; Female genital prolapse

• Registration Number: ISRCTN86144697
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

All women admitted for primary pelvic organ prolapse surgery with grade 2 or more pelvic organ prolapse who are willing to participate in the trial. Women undergoing concurrent hysterectomy or continence procedures will also be eligible.

Exclusion Criteria

Women with less than a grade 2 prolapse, those unwilling or unable to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of (or failure to cure) prolapse symptoms. One of the aims of the feasibility study is to test how best to assess these outcome measures and their inclusiveness.

Secondary Outcome Measures

Name	Time	Method
1. Immediate and late postoperative morbidity<br>2. Recurrence of prolapse<br>3. Quality of life<br>4. Satisfaction with surgery and economic outcomes