Efficacy Study of Vaginal Mesh for Prolapse

Minimally invasive surgical procedures using mesh have rapidly developed in the field of
pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the
technical advancements. No randomized controlled trials of different vaginal apical
suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due
to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial
will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery
for vaginal Stage II-IV prolapse.

Inclusion Criteria:

- Woman > 21 yrs

- Stage II-IV vaginal prolapse

- Desires vaginal reconstructive surgery

- Able to complete study questionnaires and assessments

- Uterus < 12 weeks size

- Available for 12 months follow-up

Exclusion Criteria:

- Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection,
history of pelvic irradiation, history of lower urinary tract malignancy, chronic
steroid use or a compromised immune system.

- Current intermittent catheterization.

- Pregnancy or desire for future fertility.

- Presence of an adnexal mass.

- Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).

- Other laparoscopic or abdominal/pelvic surgery in the past 3 months.

- Known neurologic or medical condition affecting bladder function, e.g. Multiple
Sclerosis, spinal cord injury.

- Need for concomitant surgery requiring an abdominal incision.

- < 12 months post-partum.

- Non-english speaking