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Updated: May 27, 2026

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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.

Journal of Obstetrics and Gynaecology Canada : JOGC = Journal D'Obstetrique Et Gynecologie Du Canada : JOGC
|November 16, 2011
PubMed
Summary

This study found that avoiding cystocele plication during transvaginal repair is feasible. Further multicenter trials are needed to confirm its short-term and long-term benefits and risks.

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Area of Science:

  • Urology
  • Gynecology
  • Surgical Innovation

Background:

  • Transvaginal cystocele repair is a common procedure.
  • The role of plication sutures in improving outcomes is not fully established.
  • Postoperative catheterization duration is a key concern.

Purpose of the Study:

  • To assess the feasibility of a single-centre randomized controlled trial (RCT).
  • To investigate if avoiding cystocele plication reduces the need for catheterization post-transvaginal repair.
  • To evaluate recruitment success, physician acceptance, and protocol adherence.

Main Methods:

  • Randomized assignment of patients undergoing transvaginal cystocele repair to either plication or no-plication groups.
  • Assessment of recruitment rates (target: 85%).

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  • Evaluation of physician preference and adherence to the randomized protocol.

    • Main Results:

    • Successful recruitment of 22 women (85% rate).
    • Surgeons reported no preference for either surgical technique.
    • No protocol violations or instances of postoperative voiding dysfunction were observed.

    Conclusions:

    • Conducting a multicentre RCT on avoiding plication sutures is feasible.
    • Further research is necessary to determine the short- and long-term risks and benefits.
    • Patient and physician support is crucial for future trial success.