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

NICHD Pelvic Floor Disorders Network

Status: Active, not recruiting

Conditions: Visceral Prolapse

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

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT02676973

1U10HD069013 (U.S. NIH Grant/Contract)

1U10HD069025 (U.S. NIH Grant/Contract)

2U10HD041267 (U.S. NIH Grant/Contract)

U10HD041263 (U.S. NIH Grant/Contract)

2U10HD054214 (U.S. NIH Grant/Contract)

1U01HD069031-01 (U.S. NIH Grant/Contract)

2U10HD041261 (U.S. NIH Grant/Contract)

1U10HD069010 (U.S. NIH Grant/Contract)

1U10HD069006 (U.S. NIH Grant/Contract)

2U10HD054215 (U.S. NIH Grant/Contract)

27P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

360 participants in 3 patient groups

Sacral Colpopexy

Active Comparator group

Description:

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

Treatment:

Procedure: Open, Robotic, or Laparoscopic

Transvaginal Native Tissue Repair

Active Comparator group

Description:

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

Treatment:

Procedure: Transvaginal Native Tissue Repair

Apical Transvaginal Mesh Repair

Active Comparator group

Description:

Uphold™ LITE

Treatment:

Procedure: Uphold™ LITE