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

Radboud University Medical Center

Status

Completed

Conditions

Pelvic Organ Prolapse

Treatments

Device: Tensionfree vaginal mesh kit (Prolift)

Procedure: classic vaginal prolapse surgery (fascia plication)

Study type

Interventional

Funder types

Other

Identifiers

NCT00372190

P0609

Details and patient eligibility

About

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.

Full 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.

Enrollment

194 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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