Prolapse Urological and Genital Diseases Female genital prolapse
Conditions
Interventions
A randomised controlled trial using a 2x2 factorial design of absorbable mesh compared with no mesh, and two types of sutures for anterior or posterior pelvic organ prolapse repair.
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria: Women with less than a grade 2 prolapse, those unwilling or unable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Immediate and late postoperative morbidity 2. Recurrence of prolapse 3. Quality of life 4. Satisfaction with surgery and economic outcomes | — |
Countries
United Kingdom
Outcome results
None listed