A randomised controlled trial comparing the performance of tension free vaginal mesh (Prolifttm) versus conventional vaginal prolapse surgery in recurrent prolapse
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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.
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.
Women with a recurrence of pelvic organ prolapse POP-Q stage 2 or more.
Tensionfree Vaginal Mesh (Prolift) or standard prolapse surgery without mesh (i.e. fascial plication).
Pre- and postoperatively POP-Q measurement
Disease-specific quality-of-life questionnaires
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.
Three months for logistics of the study set up, 28 months for recruitment and 14 months for the final data collection and evaluation.
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
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
Dr. JCM Hendriks, statistician UMC St. Radboud