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

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.

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.

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 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.