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Randomized controlled trial of cystocele plication risks: a pilot study
Victor Miranda1, May Alarab, Kellie Murphy
1Mount Sinai Hospital, Department of Obstetrics and Gynecology, University of Toronto, Toronto ON.
Objective:
We wished to determine the feasibility of a single-centre randomized controlled trial to investigate whether avoiding cystocele plication in women undergoing transvaginal repair of cystocele decreases the need for catheterization beyond the second postoperative day.
Methods:
Patients undergoing transvaginal repair of cystocele were randomly assigned to either have or not have plication sutures during their procedure. We assessed the success of recruitment, physician acceptability, and adherence to protocol, and we also assessed the need for catheterization beyond the second postoperative day.
Results:
Twenty-two women were randomized (a recruitment rate of 85%), and participating surgeons did not feel that one surgical technique was superior to the other. There were no protocol violations after randomization. No cases of postoperative voiding dysfunction were identified.
Conclusion:
A multicentre randomized controlled trial is required to determine the short-term and long-term risks and benefits of avoiding plication sutures in women undergoing transvaginal repair of cystocele. If patients and physicians support the study protocol, conducting such a trial is feasible.
