Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Prospective and Comparative Study of the Performance of Tension Free Vaginal Mesh (Prolift) Versus Conventional Vaginal Prolapse Surgery in Recurrent Prolapse

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Device: Tensionfree vaginal mesh kit (Prolift)
* Procedure: classic vaginal prolapse surgery (fascia plication)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent anterior and/or posterior prolapse POP-Q stage 2 or more patient has agreed to undergo implantation of TVM (prolift) or fascial plication patient is willing to return for follow-up evaluation at 6 weeks, 6 months and 12 months patient is willing to complete quality of life questionnaires at 6 and 12 months Exclusion Criteria: patient is or wants to become pregnant patient has had previous synthetic mesh procedure (a previous mid-urethral sling procedure is NOT an exclusion criterion) patient has current urinary tract or vaginal infections patient has a blood coagulation disorder patient has a compromised immune system or any other condition that would compromise healing patient has renal insufficiency and/or upper urinary tract obstruction patient is unwilling or unable to return for evaluation patient has had previous irradiation patient has any malignancy patient has large ovarian cysts of large myoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh surgery<br>Trocar guided tension free vaginal mesh insertion by Prolift mesh kit | Device: Tensionfree vaginal mesh kit (Prolift)<br>* Insertion of a tension free vaginal mesh using a Prolift mesh kit<br>* Other names: Prolift mesh;|
| Active Comparator: Conventional vaginal surgery<br>Classical vaginal prolapse surgery (fascia plication) | Procedure: classic vaginal prolapse surgery (fascia plication)<br>* classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse<br>* Other names: Conventional;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse by Pelvic Organ Prolapse Quantification System (POP-Q), at 12 Months | Number of participants with anatomic failures defined as Pelvic Organ Prolapse (POP) stage II or higher | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh Exposure at 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) | 12 months | 
| Patient Global Impression of Improvement (PGI-I) at 12 Months | Number of participants with much to very much improvement compared to baseline | at 12 months | 
| Bulge Symptoms | 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) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, recurrence, mesh, complications, treatment