title: Randomized controlled trial of cystocele plication risks: a pilot study.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Mount Sinai Hospital, Department of Obstetrics and Gynecology, University of Toronto, Toronto ON.
authors.forename: Victor
authors.initials: V
authors.lastname: Miranda
authors.forename: May
authors.initials: M
authors.lastname: Alarab
authors.forename: Kellie
authors.initials: K
authors.lastname: Murphy
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Pineda
authors.forename: Harold
authors.initials: H
authors.lastname: Drutz
authors.forename: Danny
authors.initials: D
authors.lastname: Lovatsis
mesh_terms: D000328:Adult; D000368:Aged; D052858:Cystocele / Q000601:surgery*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D011182:Postoperative Care / Q000379:methods; D013536:Suture Techniques; D013537:Sutures; D014546:Urinary Catheterization; D013520:Urologic Surgical Procedures / Q000379:methods*