Active Clinical Trials

SUPER

Study of Uterine Prolapse Procedures-Randomized Trials


Uterovaginal prolapse happens when the uterus and vaginal wall bulges into or through the opening of the vagina.  Women with prolapse can often feel a bulge at the vaginal opening; we call this feeling having “bulge symptoms.”  

A physician can choose from different types of vaginal surgery to repair uterovaginal prolapse, but we don’t have enough information about which surgery provides the best symptom relief while causing the fewest problems (complications) after surgery. Often, both surgeries are combined with repairs of the front (anterior or bladder side of the vagina) and back (posterior or rectal side) sides of the vagina.  This study will compare two kinds of repairs:  

  • One type of repair involves removing the uterus (hysterectomy).  The vagina is then re-supported with sutures to the ligaments that were previously attached to the uterus (uterosacral ligaments).  This procedure is called a vaginal hysterectomy and uterosacral ligament suspension (USLS).  Most of the time there is nothing wrong with the uterus; it just has weakened support and is an “innocent bystander” in the prolapse process.  The uterus is removed to give the surgeon a better view and room to attach the vagina to the ligaments.
  • The other type of repair is to leave the uterus in place, but just re-support the uterus (hysteropexy).  The Uphold Vaginal Support System is an Intra-Vaginal approach to prolapse that utilizes a small incision and mesh only where it’s needed, and is designed to reduce the risk of erosion.

If you decide to participate in this study you will be randomized (like flipping a coin) to receive either a hysterectomy and USLS or hysteropexy (with UPHOLD) for the treatment of your uterovaginal prolapse.  This study is being done because we do not know which of these two surgeries are better for treating uterovaginal prolapse.  Randomized trials of these 2 surgeries performed with long-term follow-up are needed to evaluate the safety and effectiveness of these two procedures.  Patients and Study Coordinators will be masked throughout the duration of this study. Surgeons and anatomical evaluators will remain unmasked. 

Principal Investigator:
Dr. Lily A. Arya, MD

Sponsor:
NIH

Study Coordinator:
Lorraine Flick
215-615-6569
lorraine.flick@upsh.upenn.edu

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