Study of Uterine Prolapse Procedures - Randomized Trial

NCT01802281 | Completed Results DMC

• 1 other identifier: PFDN-24P01
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Uterovaginal Prolapse

Outcome Measures

Primary Outcomes (1)

• Cumulative Failure

  Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.

  6 Months through 36 Months

Secondary Outcomes (1)

• At-visit Failure

  6 months through 36 Months

Other Outcomes (22)

• Change From Baseline PFDI Score

  6, 12, 18, 24, and 36 Months

• Change From Baseline CRADI Score

  6, 12, 18, 24, and 36 Months

• Change From Baseline POPDI Score

  6, 12, 18, 24, and 36 Months

Study Arms (2)

Hysteropexy

ACTIVE COMPARATOR

Uphold® LITE

Procedure: Uphold® LITE

Hysterectomy and USLS

ACTIVE COMPARATOR

Vaginal hysterectomy and uterosacral ligament suspension (USLS)

Procedure: Uterosacral ligament suspension

Interventions

Uterosacral ligament suspension PROCEDURE

The USLS procedure used in this protocol is a modification of the technique described by Shull.

Hysterectomy and USLS

Uphold® LITE PROCEDURE

The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.

Hysteropexy

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 21 or older who have completed child -bearing
• Prolapse beyond the hymen (defined as Ba, Bp, or C \> 0 cm)
• Uterine descent into at least the lower half of the vagina (defined as point C\> -TVL/2) )
• Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
• Desires vaginal surgical treatment for uterovaginal prolapse
• Available for up to 60 month follow-up
• Amenorrhea for the past 12 months from either menopause or endometrial ablation
• Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
• Eligible for no cervical cancer screening for at least 3 years

You may not qualify if:

• Previous synthetic material (placed vaginally or abdominally) to augment POP repair
• Known previous uterosacral or sacrospinous uterine suspension
• Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
• Chronic pelvic pain
• Pelvic radiation
• Cervical elongation- defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).
• Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years (e.g. HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer)
• Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon
• Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
• Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Boston Scientific Corporation: collaborator

Study Sites (8)

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Birmingham, Alabama, 35249, United States

Location

University of California at San Diego, UCSD Women's Pelvic Medicine Center

La Jolla, California, 92037-0974, United States

Location

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

Albuquerque, New Mexico, 87131, United States

Location

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

Location

Cleveland Clinic, Department OB/GYN

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

Pittsburgh, Pennsylvania, 15213, United States

Location

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

Providence, Rhode Island, 02903, United States

Location

Related Publications (5)

• Bradley MS, Sridhar A, Ferrante K, Andy UU, Visco AG, Florian-Rodriguez ME, Myers D, Varner E, Mazloomdoost D, Gantz MG; NICHD Pelvic Floor Disorders Network. Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension. Urogynecology (Phila). 2023 May 1;29(5):479-488. doi: 10.1097/SPV.0000000000001309. Epub 2022 Dec 23.

  PMID: 36701331 DERIVED

• Napoe GS, Luchristt D, Sridhar A, Ellington D, Ridgeway B, Mazloomdoost D, Sung V, Ninivaggio C, Harvie H, Santiago-Lastra Y, Gantz MG, Zyczynski HM. Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment. Int Urogynecol J. 2023 Jan;34(1):255-261. doi: 10.1007/s00192-022-05411-2. Epub 2022 Nov 30.

  PMID: 36449027 DERIVED

• Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zyczynski 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. Am J Obstet Gynecol. 2021 Aug;225(2):153.e1-153.e31. doi: 10.1016/j.ajog.2021.03.012. Epub 2021 Mar 12.

  PMID: 33716071 DERIVED

• Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992.

  PMID: 32769645 DERIVED

• 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 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812.

  PMID: 31529008 DERIVED

Results Point of Contact

• Title: Marie Gantz
• Organization: RTI International

mgantz@rti.org

919-541-5110

Study Officials

• Charles W Nager, MD

  University of California at San Diego, UCSD Women's Pelvic Medicine Center

  PRINCIPAL INVESTIGATOR

• Anthony G Visco, MD

  Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

  PRINCIPAL INVESTIGATOR

• Heidi Harvie, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Marie Paraiso, MD

  Cleveland Clinic, Department OB/GYN

  PRINCIPAL INVESTIGATOR

• Charles R Rardin, MD

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

  PRINCIPAL INVESTIGATOR

• Holly E Richter, PhD, MD

  University of Alabama at Birmingham, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Kate Meriwether, MD

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

  PRINCIPAL INVESTIGATOR

• Halina M Zyczynski, MD

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

  PRINCIPAL INVESTIGATOR

• Sonia Thomas, DrPH

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 1, 2013
• Study Start: April 1, 2013
• Primary Completion: July 31, 2023
• Study Completion: March 7, 2025
• Last Updated: August 26, 2025
• Results First Posted: March 22, 2021

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)