SUPeR: Study of Uterine Prolapse Procedures- Randomized Trial

Uterine prolapse, or the dropping or sagging of the uterus (and perhaps other organs like the bladder) into the vagina is, unfortunately, a fairly common problem in women. The investigators of the Pelvic Floor Disorders Network have been very interested in comparing various treatments for prolapse in order to provide information that will help doctors develop the best treatment plan for their patients.

Treatment for prolapse often involves surgery, and there are many different surgical procedures that can be performed, depending upon the type of prolapse, a woman’s health and her preferences.  Often, repair of uterine prolapse includes removal of the uterus (hysterectomy).  An alternative procedure is one that supports the prolapsing uterus (hysteropexy) and pelvic organs.  We do not currently have enough information to tell women if there is a difference between the two surgical approaches in symptom relief, durability, risks and complications. 

In this study, the investigators are comparing two specific prolapse procedures, both done through the vagina.

One type of repair involves removing the uterus (hysterectomy).  The vagina is then re-attached to the pelvic ligaments (uterosacral ligaments) with permanent sutures.  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 way to attach the top of the vagina to the pelvic ligaments.

The other type of repair in this study involves leaving the uterus in place, and instead, re-supporting it (hysteropexy).  Retaining the uterus is an option some women would like to consider. The hysteropexy is accomplished by using the UPHOLD mesh system which effectively serves as man-made ligaments.   

Women in this study will be randomly assigned to one of the two vaginal prolapse procedures.  All participating women will complete questionnaires and a physical examination before and then for up to five years after surgery.   In this way, the investigators will be able to make comparisons between the two groups of women to see if there are differences.  Some of the questions that the investigators hope to answer include:

• Are the treatments equally supportive 3-5 years after surgery?
• How do women’s symptoms, quality of life, and physical measures compare after 3-5 years?
• What problems or complications occurred in each group, and are there differences?
• Is the success of surgery influence by certain characteristics of women, such as severity of prolapse, age, obesity, smoking, menopausal status, estrogens, previous prolapse surgery, and physical activity?
• Is one procedure more cost-effective?

This study began in March, 2013, and is expected to continue until about 2018. Recruitment and surgical procedures will occur over the first two years, and women enrolled in the study will continue to be followed afterwards for the additional three years.

We present the rationale for and design of a randomized controlled superiority trial comparing 2 vaginal surgical approaches for the treatment of uterovaginal prolapse. The Study of Uterine Prolapse Procedures Randomized Trial (SUPeR) trial compares the efficacy and safety of native tissue repair with vaginal hysterectomy and suture apical suspension versus uterine conservation with mesh hysteropexy through 36 to 60 months postoperatively for primary repair of uterovaginal prolapse.

STUDY RESULTS:

Nager CW, Zyczynski H, Rogers RG, Barber MD, Richter HE, Visco AG, Rardin CR, Harvie H, Wallace D, Meikle SF, Pelvic Floor Disorders Network. The Design of a Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy With Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension (The Study of Uterine Prolapse Procedures Randomized Trial). Female pelvic medicine & reconstructive surgery. 2016 Jul; 22(4): 182-9.

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Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Grey S, Sridhar A, Wallace D, NICHD Pelvic Floor Disorders Network. Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial. JAMA. 2019 09; 322(11): 1054-1065.

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Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zycynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S, National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. American Journal of Obstetrics and Gynecology. 2021 Mar; In Press.

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Read more about this study at clinicaltrials.gov.