Research Results

The OPTIMAL Study: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: A Randomized trial of Sacrospinous Ligament Fixation (SSLF) versus Uterosacral Ligament Suspension (ULS) with and without Perioperative Behavioral Therapy/Pelvic Muscle Training

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. Stress urinary incontinence is a condition where urine leakage occurs with coughing, laughing and other physical activities and can also be treated with surgery. Pelvic organ prolapse and stress urinary incontinence often occur together and can be treated simultaneously.

The Operations and Pelvic Muscle Training In the Management of Apical support loss (OPTIMAL) trial has two main objectives. The first is to compare two different methods of suspending the prolapsed vagina using a vaginal approach in women with both pelvic organ prolapse and stress urinary incontinence, sacrospinous ligament suspension and uterosacral ligament suspension. Both types of surgery are commonly used but have never been directly compared. The second objective of the trial is to evaluate the value of pelvic muscle training before and after surgery to see if it improves short and long-term results after surgery. Pelvic muscle training is not currently standard of care for women having prolapse surgery, so this study investigates the value of this additional therapy.

The results from the OPTIMAL study will help answer a number of important questions for women with pelvic organ prolapse and stress urinary incontinence who are planning vaginal surgery:

• Which surgical approach is more effective for treating pelvic organ prolapse in women undergoing vaginal surgery: sacrospinous ligament suspension or uterosacral ligament suspension?

• Does the addition of pelvic muscle training before and after surgery improve urinary outcomes in women undergoing vaginal surgery for pelvic organ prolapse and stress urinary incontinence?

• Does the addition of pelvic muscle training before and after surgery improve the long-term success of vaginal prolapse surgery?

• Are the costs to society and patients of routinely performing pelvic muscle training before and after prolapse surgery worth the benefit?