Surgical Procedures for Uterovaginal Prolapse

(SUPeR Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Charles W Nager, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NICHD Pelvic Floor Disorders Network

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years. A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.

Eligibility Criteria

This trial is for women over 21 who've finished having children, are not pregnant, and can follow up for up to 5 years. They should have uterovaginal prolapse beyond the hymen with bothersome symptoms but no history of certain pelvic treatments or conditions that would exclude them from safe participation.

Inclusion Criteria

Available for up to 60 month follow-up

My pelvic organ prolapse extends beyond the vaginal opening.

Amenorrhea for the past 12 months from either menopause or endometrial ablation

Exclusion Criteria

I have received radiation therapy to my pelvis.

My cervix is expected to be low in position after a specific pelvic surgery.

I am at high risk for cervical issues and need screenings more often due to factors like HIV, immune suppression, DES exposure, or past treatments.

Participant Groups

The study compares two surgical methods for fixing uterine prolapse: a mesh-augmented hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension. It aims to see which method is more effective over three years.

Group I: Hysterectomy and USLS Active Control 1 Intervention

Vaginal hysterectomy and uterosacral ligament suspension (USLS)

Group II: Hysteropexy Active Control 1 Intervention

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Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology Albuquerque, NM

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery Durham, NC

Magee-Women's Hospital, Department of Obstetrics and Gynecology Pittsburgh, PA

Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery Providence, RI

More Trial Locations

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network Lead Sponsor

Boston Scientific Corporation Industry Sponsor

References