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

Radboud University Medical Center194 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

194

Conditions

Pelvic Organ Prolapse

Interventions

Tensionfree vaginal mesh kit (Prolift)DEVICE

Insertion of a tension free vaginal mesh using a Prolift mesh kit

classic vaginal prolapse surgery (fascia plication)PROCEDURE

classic vaginal prolapse surgery (fascia plication) to correct Pelvic Organ prolapse

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Gelre ziekenhuizen

Apeldoorn, Netherlands

Slysis Zorggroep, location Rijnstate

Arnhem, Netherlands

Reinier de Graaf Gasthuis

Delft, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

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)

Time frame: 12 months

"Patient Global Impression of Improvement" (PGI-I) at 12 Months

Number of participants with much to very much improvement compared to baseline

Time frame: 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)

Time frame: 12 months

Data from ClinicalTrials.gov

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