Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

Not Applicable

Active, not recruiting

Conditions: Visceral Prolapse

Interventions: Procedure: Transvaginal Native Tissue Repair
Procedure: Uphold™ LITE
Procedure: Open, Robotic, or Laparoscopic

Registration Number: NCT02676973

Lead Sponsor: NICHD Pelvic Floor Disorders Network

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.

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.

Detailed Description: The primary purpose of this three arm randomized clinical trial is to determine if apical transvaginal mesh placement is non-inferior to sacral colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse and to determine if mesh reinforced repairs performed by abdominal or vaginal approach are superior to native tissue vaginal repair. This trial has the following primary aims:

1. To determine if Apical Transvaginal Mesh is non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.

1A. In the case where Apical Transvaginal Mesh is shown to be statistically significantly non-inferior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years, to determine if Apical Transvaginal Mesh is superior to Sacral Colpopexy for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.

2. To determine if Sacral Colpopexy is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.

3. To determine if Apical Transvaginal Mesh is superior to Native Tissue Repair for anatomic correction of post-hysterectomy vaginal vault prolapse at time points through 3 years.

Additional secondary aims include:

1. Evaluate the development of a valid and reliable Global Composite Outcome that balances adverse events and patient-centered outcomes to anatomic definitions of failure and success.

2. Determine the impact of preoperative frailty and mobility on surgical treatment outcomes and postoperative complications of older women following surgical correction of apical pelvic organ prolapse.

3. Evaluate the patient's perspective about adverse events and their role in patient decision-making outcomes. The aims include comparing patient versus surgeon rankings of complication grade, outcome, expectedness and seriousness, to estimate the association between patient rankings of adverse events (AEs) with decision-making and quality of life outcomes and to determine if their perspective about AEs changes over time.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 360

Inclusion Criteria

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

Exclusion Criteria

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:
    - Only documented SSLS will be an exclusion.
    - Mesh used for only mid-urethral sling will NOT be an exclusion
    - 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal Native Tissue Repair	Transvaginal Native Tissue Repair	Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)
Apical Transvaginal Mesh Repair	Uphold™ LITE	Uphold™ LITE
Sacral Colpopexy	Open, Robotic, or Laparoscopic	Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.

Primary Outcome Measures

Name	Time	Method
Number of Participants Considered Failures	6 months through 60 Months	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Kaiser Permanente
🇺🇸
San Diego, California, United States
University of California at San Diego
🇺🇸
San Diego, California, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Brown/Women and Infants Hospital of Rhode Island
🇺🇸
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States
University of New Mexico
🇺🇸
Albuquerque, New Mexico, United States
Duke University
🇺🇸
Durham, North Carolina, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States