OPUS

Pelvic organ prolapse is a condition where the pelvic organs (the uterus, bladder, rectum or small bowel) sag into or through the vagina, creating a bulge. Pelvic organ prolapse is common and happens to some degree in one-third of women. When pelvic organ prolapse causes symptoms or discomfort, it can be treated with surgery. Surgery can be done using either a vaginal or abdominal incision. While surgery is quite effective at fixing the symptoms from the bulge, some women develop new stress urinary incontinence (leakage with coughing, sneezing and activities) after surgery.

A prior PFDN randomized trial showed that adding an abdominal anti-leakage surgery (called a Burch colposuspension) at the time of abdominal surgery for pelvic organ prolapse (called abdominal sacrocolpopexy) helped to prevent leakage in some women after surgery, without increasing risk. However, we don’t know if this holds true for women getting vaginal surgery for prolapse, because each type of surgery changes the anatomy of the pelvis differently, and each type of anti-leakage surgery has different risks.

The objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether doing a vaginal anti-incontinence surgery (called the Tension-free Vaginal Tape, or TVT) at the time of vaginal prolapse surgery helps to cut down on urinary incontinence in women without stress urinary incontinence before surgery.

The results from the OPUS study will help answer a number of important questions for women without stress urinary incontinence who are planning vaginal surgery for pelvic organ prolapse:

• Is the rate of significant urinary incontinence different between women that get vaginal prolapse repair versus vaginal prolapse repair plus TVT during the first 3 months after the surgery?
• A year after surgery, are women equally dry and satisfied whether they get the TVT at the time of prolapse surgery or whether they get treatment for urinary leakage, if needed, during the year after surgery?
• Which costs society and patients more: doing a TVT in all women at the time of vaginal prolapse surgery or waiting to treat those that end up with leakage problems after surgery?

STUDY RESULTS SUMMARY

Jelovsek JE, et al. A model for predicting the risk of de novo stress urinary incontinence in women undergoing pelvic organ prolapse surgery. Obstet Gynecol. 2014 Feb.

Nager CW, et al. Concomitant Anterior Repair, Preoperative Prolapse Severity, and Anatomic Prolapse Outcomes After Vaginal Apical Procedures. Female Pelvic Med Reconstr Surg. 2019 Jan/Feb.

Rogers RG, et al. Surgical Outcomes After Apical Repair for Vault Compared With Uterovaginal Prolapse. Obstet Gynecol. 2018 Mar.

Brubaker L, et al. Effectiveness of blinding: sham suprapubic incisions in a randomized trial of retropubic midurethral sling in women undergoing vaginal prolapse surgery. Am J Obstet Gynecol. 2014 Nov.

Wei JT, et al. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21.

Brubaker L, et al. Quantification of vaginal support: are continuous summary scores better than POPQ stage?. Am J Obstet Gynecol. 2010 Nov.

Wei JT, et al. Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods. Clin Trials. 2009 Apr.

ClinicalTrials.gov

ClinicalTrials.Gov ID: NCT00460434