NCT02676973

Brief Summary

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. 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). The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2016Dec 2026

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

February 29, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 17, 2024

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

6.4 years

First QC Date

November 30, 2015

Results QC Date

August 31, 2023

Last Update Submit

August 6, 2025

Conditions

Visceral Prolapse

Keywords

pelvic organ prolapsePOPvault prolapsecystocelevaginal prolapsepost-hysterectomy vaginal prolapse

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Considered Failures

    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 60 Months

Other Outcomes (20)

  • Change From Baseline PFDI Score

    6 months through 60 Months

  • Change From Baseline CRADI Score

    6 months through 60 Months

  • Change From Baseline POPDI Score

    6 months through 60 Months

  • +17 more other outcomes

Study Arms (3)

Sacral Colpopexy

ACTIVE COMPARATOR

Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.

Procedure: Open, Robotic, or Laparoscopic

Transvaginal Native Tissue Repair

ACTIVE COMPARATOR

Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)

Procedure: Transvaginal Native Tissue Repair

Apical Transvaginal Mesh Repair

ACTIVE COMPARATOR

Uphold™ LITE

Procedure: Uphold™ LITE

Interventions

Open, Robotic, or LaparoscopicPROCEDURE

Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.

Sacral Colpopexy
Transvaginal Native Tissue RepairPROCEDURE

Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).

Transvaginal Native Tissue Repair
Uphold™ LITEPROCEDURE

Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.

Apical Transvaginal Mesh Repair

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 21 or older
  • Prior total hysterectomy (no cervix present)
  • Prolapse beyond the hymen (defined as Ba, C, or Bp \> 0 cm)
  • Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C\> -2/3 TVL)
  • Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
  • Desires surgical treatment for post-hysterectomy vaginal prolapse
  • Available for up to 60 month follow-up

You may not qualify if:

  • Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments
  • Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse \*
  • Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
  • Unresolved chronic pelvic pain-active
  • Prior abdominal or pelvic radiation
  • Contraindication to any of the index surgical procedures
  • Known Horseshoe Kidney or Pelvic Mass overlying the sacrum
  • Active diverticular abscess or active diverticulitis
  • Shortened vaginal length (\<6 cm TVL)
  • NOTE:
  • If prior POP repair is unknown and unable to be documented, subjects will be eligible based on clinician judgment. The investigator will examine and assess for evidence of mesh or graft if no evidence of mesh or graft is present on examination subject remains eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California at San Diego

San Diego, California, 92037, United States

Location

Kaiser Permanente

San Diego, California, 92110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Duke University

Durham, North Carolina, 27707, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19118, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown/Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

  • Menefee SA, Richter HE, Myers D, Moalli P, Weidner AC, Harvie HS, Rahn DD, Meriwether KV, Paraiso MFR, Whitworth R, Mazloomdoost D, Thomas S; NICHD Pelvic Floor Disorders Network. Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial. JAMA Surg. 2024 Aug 1;159(8):845-855. doi: 10.1001/jamasurg.2024.1206.

    PMID: 38776067DERIVED

  • Sung VW, Menefee S, Richter HE, Moalli PA, Andy U, Weidner A, Rahn DD, Paraiso MF, Jeney SE, Mazloomdoost D, Gilbert J, Whitworth R, Thomas S; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Patient perspectives in adverse event reporting after vaginal apical prolapse surgery. Am J Obstet Gynecol. 2024 Aug;231(2):268.e1-268.e16. doi: 10.1016/j.ajog.2024.04.043. Epub 2024 May 6.

    PMID: 38710268DERIVED

  • Sung VW, Menefee S, Dunivan G, Richter HE, Moalli P, Weidner A, Andy UU, Jelovsek E, Mazloomdoost D, Whitworth R, Thomas S; NICHD Pelvic Floor Disorders Network. Design of a Study to Measure Patient-Perspectives in Adverse Event Reporting (the PPAR Study): Supplementary Study to the ASPIRe Trial. Female Pelvic Med Reconstr Surg. 2021 Jan 1;27(1):e112-e117. doi: 10.1097/SPV.0000000000000845.

    PMID: 32487881DERIVED

  • Menefee S, Richter HE, Myers D, Weidner A, Moalli P, Harvie H, Rahn D, Jeppson P, Paraiso M, Thomas S, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial. Female Pelvic Med Reconstr Surg. 2020 Jul;26(7):415-424. doi: 10.1097/SPV.0000000000000803.

    PMID: 31860566DERIVED

MeSH Terms

Conditions

Visceral ProlapsePelvic Organ ProlapseCystoceleUterine Prolapse

Interventions

Robotics

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUterine DiseasesGenital Diseases, FemaleGenital Diseases

Intervention Hierarchy (Ancestors)

AutomationTechnologyTechnology, Industry, and Agriculture

Results Point of Contact

Title
Marie Gantz
Organization
RTI International
mgantz@rti.org
919-541-5110

Study Officials

  • Shawn Menefee, MD

    Kaiser Permanente San Diego

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

February 9, 2016

Study Start

February 29, 2016

Primary Completion

July 28, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

August 26, 2025

Results First Posted

May 17, 2024

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)