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 > VROUW
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VROUW trial


A randomised controlled trial comparing the performance of tension free vaginal mesh (Prolifttm) versus conventional vaginal prolapse surgery in recurrent prolapse

Go to the VROUW page

 

Objective

This study is designed to determine the effectiveness of the Tensionfree Vaginal Mesh (Prolift), compared with the standard prolapse surgery (i.e. fascial placation) in recurrent prolapse.  Objective and subjective outcomes will be assessed by follow up physical examinations and subject self-report.  Objective assessment will be performed pre- and postoperatively with a POP-Q test and disease-specific Quality-of-Life questionnaires.

A secondary objective is to track the post-operative and long-term complications of both procedures. Safety will be evaluated by measuring rates of complications, recorded on a specified case report form (CRF); during the procedure and at post procedure follow-up visits.  The reporting of adverse events through physical examination and subject self-report will be used to assess these complications.

 

Study design

This study is a prospective, multicentre, randomized, non-blinded study.  Evaluation will take place in every centre 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.

 

Study population

Women with a recurrence of pelvic organ prolapse POP-Q stage 2 or more.

 

Intervention

Tensionfree Vaginal Mesh (Prolift) or standard prolapse surgery without mesh (i.e. fascial plication).

 

Outcome measures

Pre- and postoperatively POP-Q measurement

Disease-specific quality-of-life questionnaires

Complications

 

Power/data analysis

On the assumption of  a prolapse recurrence of 30% in the conventional prolapse operation group (cure rate of 70%) and a prolapse recurrence of maximal 13% in the Prolift group (minimal cure rate of 87%) it was calculated that 88 patients would be required in each arm with a 80% power. 

With a drop-out rate of 10% 97 women in each arm of the study are needed. A total of 194 women with a recurrence of vaginal prolapse after previous prolapse surgery will be included from the participating centers.

 

Time schedule

Three months for logistics of the study set up, 28 months for recruitment and 14 months for the final data collection and evaluation.

 

Participating hospitals

UMC St Radboud, Nijmegen

Reinier de Graaf Groep, Delft

St. Elisabeth ziekenhuis, Tilburg

Isala kliniek, Zwolle

Tweesteden ziekenhuis, Tilburg

Ikazia ziekenhuis, Rotterdam

Medisch Spectrum Twente, Enschede

Refaja ziekenhuis, Stadskanaal

St. Antonius ziekenhuis, Nieuwegein

Groene Hart ziekenhuis, Gouda

Gelre ziekenhuizen, Apeldoorn

Alysis zorggroep, Arnhem

Nijsmellinghe, Drachten

 

Projectleaders

M.I.J. Withagen, gynaecologist UMC St. Radboud

Prof. Dr. M.E. Vierhout, gynaecologist UMC St. Radboud

Dr. H.A.M. Vervest, gynaecologist St. Elisabeth ziekenhuis

 

Methodology

Dr. JCM Hendriks, statistician UMC St. Radboud

 

Subsidy

none