Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.
Pelvic organ prolapse is a common problem. A lot of women have surgery for prolapse. The recurrence rate op pelvic organ prolapse after surgical treatment is high. Placement of a mesh aims at reducing the recurrence rate, but mesh implants can cause complications.
This study is designed to determine the effectiveness of one type of mesh (tensionfree vaginal mesh; Prolift), compared with the standard prolapse surgery. A secondary objective is to track the complications of both procedures.
|Pelvic Organ Prolapse||Device: Tensionfree vaginal mesh kit (Prolift) Procedure: classic vaginal prolapse surgery (fascia plication)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse|
- Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months [ Time Frame: 12 months ]Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher
- Mesh Exposure at 12 Months [ Time Frame: 12 months ]cumulative number of patients with mesh exposure at 12 months (if diagnosed at 6 weeks or 6 months and treated, the exposure is calculated at 12 months, even if the exposure was not there anymore)
- "Patient Global Impression of Improvement" (PGI-I) at 12 Months [ Time Frame: at 12 months ]Number of participants with much to very much improvement compared to baseline
- Bulge Symptoms [ Time Frame: 12 months ]
Bulge symptoms defined as Prolapse domain score of the "Urogenital Distress Inventory" (UDI) at 12 months.
Scores range from 0 (least/no bother) to 100 (maximum bother)
|Study Start Date:||August 2006|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Mesh surgery
Trocar guided tension free vaginal mesh insertion by Prolift mesh kit
Device: Tensionfree vaginal mesh kit (Prolift)
Insertion of a tension free vaginal mesh using a Prolift mesh kit
Other Name: Prolift mesh
Active Comparator: Conventional vaginal surgery
Classical vaginal prolapse surgery (fascia plication)
Procedure: classic vaginal prolapse surgery (fascia plication)
classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse
Other Name: Conventional
Patients with recurrent prolapse after surgery can participate in this study. A total of 194 women will be included. At random 97 patients undergo a standard prolapse operation and 97 patients undergo an operation with the mesh. Evaluation will take place during surgery, at the postoperative visit after six weeks, and after six months and twelve months. Quality of life, degree of vaginal prolapse, subjective effectiveness, safety and incidence of complications will be evaluated.
An amendment to the original study has been approved by the Ethical Committee to examine long term outcome of this RCT at 7 years. This study was completed in december 2015.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372190
|Slysis Zorggroep, location Rijnstate|
|Reinier de Graaf Gasthuis|
|Medisch Spectrum Twente|
|Groene Hart Ziekenhuis|
|St. Antonius Ziekenhuis|
|UMC St Radboud|
|St. Elisabeth hospital|
|Twee Steden Ziekenhuis|
|Zaans Medisch Centrum|
|Principal Investigator:||Mariella ij Withagen, Drs.||UMC St Radboud|