Study of Uterine Prolapse Procedures - Randomized Trial

NCT ID: NCT01802281

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-01
• Study Completion Date: 2025-03-07

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.

Detailed Description

The study population will be adult women (>21 years of age) with symptomatic uterovaginal prolapse at or beyond the hymen who desire vaginal surgical management. This study is intended to be done only on women who have completed child-bearing and have an inactive uterus, defined as amenorrhea for 1 year. Therefore women will be postmenopausal or will have amenorrhea from an endometrial ablation. Amenorrhea caused from exogenous steroids, or hypothalamic disorders will not allow inclusion.

Participants will be obtained from the clinic population of each of the eight Pelvic Floor Disorders Network (PFDN) sites. Participants will be randomly assigned to have either vaginal hysterectomy and USLS or mesh hysteropexy suspension for treatment of their uterovaginal prolapse. The surgical assignment will be revealed in the operating room, after the participant is under anesthesia.

Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years). Follow-up data will be obtained during in-person clinic visits, and study staff who are masked to the surgical assignment will be the primary person who obtain follow-up data. Although the primary study outcome does not depend on masked participants and blinded evaluators, several important participant reported secondary aims are subject to reporting bias if the participant is aware of her study assignment. Therefore, study participants, coordinators, and nurses will be masked to the study assignment. Study surgeons and anatomic evaluators will be unmasked. Evaluators conducting the POPQ exam will be a co-investigator, fellow or other qualified nurse who did not perform the study surgery.

Surgical failure rates will be compared using survival analysis approaches appropriate for interval censored data (classic log-rank tests and survival models using a generalized linear model approach with a complementary log-log link) and secondary outcomes will be reported as rates in each group or as group means and evaluated with the appropriate parametric or nonparametric statistical tests.

Throughout the study, the PFDN Data Safety and Monitoring Committee (DSMB) will review study data and decide if the study can or cannot continue. Additionally, this study will adhere to the CONSORT guidelines for performing and reporting randomized controlled trials (Begg et al 1996). Women who are eligible but decline enrollment will be characterized in a manner consistent with CONSORT requirements.

Conditions

Uterovaginal Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hysteropexy

Uphold® LITE

Group Type: ACTIVE_COMPARATOR

Uphold® LITE

Intervention Type: PROCEDURE

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

Hysterectomy and USLS

Vaginal hysterectomy and uterosacral ligament suspension (USLS)

Group Type: ACTIVE_COMPARATOR

Uterosacral ligament suspension

Intervention Type: PROCEDURE

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

Interventions

Uterosacral ligament suspension

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

Intervention Type: PROCEDURE

Uphold® LITE

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Women aged 21 or older who have completed child -bearing

2. Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)

3. Uterine descent into at least the lower half of the vagina (defined as point C> -TVL/2) )

4. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'

5. Desires vaginal surgical treatment for uterovaginal prolapse

6. Available for up to 60 month follow-up

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

8. Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)

9. Eligible for no cervical cancer screening for at least 3 years

Exclusion Criteria

1. Previous synthetic material (placed vaginally or abdominally) to augment POP repair

2. Known previous uterosacral or sacrospinous uterine suspension

3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess

4. Chronic pelvic pain

5. Pelvic radiation

6. 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).

7. 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)

8. 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

9. Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)

10. Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

NICHD Pelvic Floor Disorders Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles W Nager, MD

Role: PRINCIPAL_INVESTIGATOR

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

Anthony G Visco, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Heidi Harvie, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Marie Paraiso, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Department OB/GYN

Charles R Rardin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Holly E Richter, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Kate Meriwether, MD

Role: PRINCIPAL_INVESTIGATOR

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

Halina M Zyczynski, MD

Role: PRINCIPAL_INVESTIGATOR

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

Sonia Thomas, DrPH

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

University of Alabama at Birmingham, Department of Obstetrics and Gynecology

Birmingham, Alabama, United States

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

La Jolla, California, United States

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

Albuquerque, New Mexico, United States

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, United States

Cleveland Clinic, Department OB/GYN

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Pittsburgh, Pennsylvania, United States

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

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36701331 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36449027 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33716071 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32769645 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31529008 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PFDN-24P01

Identifier Type: -

Identifier Source: org_study_id