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

Not Applicable

Completed

Interventions: Device: Tensionfree vaginal mesh kit (Prolift)
Procedure: classic vaginal prolapse surgery (fascia plication)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mesh surgery	Tensionfree vaginal mesh kit (Prolift)	Trocar guided tension free vaginal mesh insertion by Prolift mesh kit
Conventional vaginal surgery	classic vaginal prolapse surgery (fascia plication)	Classical vaginal prolapse surgery (fascia plication)

Primary Outcome Measures

Name	Time	Method
Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months	12 months	Number of participants with anatomic failures defined as "Pelvic Organ Prolapse" (POP) stage II or higher

Secondary Outcome Measures

Name	Time	Method
Bulge Symptoms	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)
Mesh Exposure at 12 Months	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	at 12 months	Number of participants with much to very much improvement compared to baseline

Locations (13): UMC St Radboud
🇳🇱
Nijmegen, Netherlands
Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Refaja
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Stadskanaal, Netherlands
Isala klinieken
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Zwolle, Netherlands
Slysis Zorggroep, location Rijnstate
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Arnhem, Netherlands
Groene Hart Ziekenhuis
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Gouda, Netherlands
Ikazia
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Rotterdam, Netherlands
St. Elisabeth hospital
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Tilburg, Netherlands
St. Antonius Ziekenhuis
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Nieuwegein, Netherlands
Zaans Medisch Centrum
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Zaandam, Netherlands
Gelre ziekenhuizen
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Apeldoorn, Netherlands
Reinier de Graaf Gasthuis
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Delft, Netherlands
Twee Steden Ziekenhuis
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Tilburg, Netherlands