Clinical trial NCT02676973: Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Official title: Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Visceral Prolapse
Keywords: pelvic organ prolapse
POP
vault prolapse
cystocele
vaginal prolapse
post-hysterectomy vaginal prolapse
Lead sponsor: NICHD Pelvic Floor Disorders Network
Sponsor class: NETWORK
Collaborators: name: The Cleveland Clinic
name: University of Alabama at Birmingham
name: University of California, San Diego
name: Duke University
name: University of New Mexico
name: Women and Infants Hospital of Rhode Island
name: RTI International
name: University of Pennsylvania
name: University of Pittsburgh
name: Kaiser Permanente
name: University of Texas Southwestern Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-02-09
Enrollment: 360
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments
2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse \*
3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
4. Unresolved chronic pelvic pain-active
5. Prior abdominal or pelvic radiation
6. 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.

Primary outcomes:
measure: Number of Participants Considered Failures
timeFrame: 6 months through 60 Months
Secondary outcomes:
Other outcomes:
measure: Change From Baseline PFDI Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline CRADI Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline POPDI Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline UDI Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline PFIQ Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline CRAIQ Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline POPIQ Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline UIQ Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline Functional Activity Scale
timeFrame: 6 months through 60 Months
measure: Change From Baseline Body Part Pain Scale
timeFrame: 6 months through 60 Months
measure: Change From Baseline Surgical Pain Scale Rest Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline Surgical Pain Scale Normal Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline Surgical Pain Scale Exercise Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline Surgical Pain Scale Worst Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline PISQ-IR Sexually Active Average Score
timeFrame: 6 months through 60 Months
measure: Change From Baseline POP-Q Ba Measurement
timeFrame: 6 months through 60 Months
measure: Change From Baseline POP-Q Bp Measurement
timeFrame: 6 months through 60 Months
measure: Change From Baseline POP-Q C Measurement
timeFrame: 6 months through 60 Months
measure: Change From Baseline POP-Q TVL Measurement
timeFrame: 6 months through 60 Months
measure: Number of Participants With PGI-I Reported Improvement
timeFrame: 6 months through 60 Months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Brown/Women and Infants Hospital of Rhode Island
state: Rhode Island
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Kaiser Permanente San Diego
name: Shawn Menefee, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.