Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

The overall objective of this randomized clinical trial is to determine whether
symptom-specific treatment of incontinence after prolapse surgery is equally effective to
prophylactic treatment by adding TVT® at the time of the prolapse surgery among women with
anterior vaginal prolapse but without pre-operative symptoms of stress urinary incontinence.

The primary aims are:

In stress continent women planning vaginal surgery for pelvic organ prolapse:

1. To determine if the failure rate defined by subsequent treatment for urinary
incontinence, signs or symptoms of bothersome urinary incontinence [defined as having at
least moderate bother for any of 4 Pelvic Floor Distress Inventory (PFDI) incontinence
items] differs between vaginal prolapse repair and vaginal prolapse repair plus TVT®
during the first 3 months after the index surgery.

2. To determine if the prevalence of bothersome urinary incontinence at 12 months after the
index surgery differs between vaginal prolapse repair and vaginal prolapse repair plus
TVT®, whether or not there was subsequent treatment for symptoms of urinary
incontinence; i.e., to determine whether symptom-specific treatment of incontinence
after prolapse surgery is equally effective to prophylactic treatment by adding a TVT®
at the time of the prolapse surgery.

3. To measure the total cost of care and relate the difference in cost of care between the
two groups to differences in health utilities and health-related quality of life, which
will allow us to examine the cost-effectiveness of prophylactic use of a TVT® at the
time of prolapse surgery versus symptom-specific treatment of stress incontinence after
prolapse surgery.

Inclusion Criteria:

Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5
of the PFDI:

- Do you usually have a sensation of bulging or protrusion from the vaginal area?

- Do you usually have a bulge or something falling out that you can see or feel in the
vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse
quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).

Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.

Able and willing to complete data collection per protocol, including written informed
consent.

Exclusion Criteria:

Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral
sling. Currently participating in another interventional study for urinary incontinence.

Untreated urinary tract infection (may be included after resolution).

Overt symptoms of stress urinary incontinence as defined by a positive response to any of
the following 3 PFDI items:

- Do you usually experience urine leakage related to coughing, sneezing, or laughing?

- Do you usually experience urine leakage related to physical exercise such as walking,
running, aerobics, or tennis?

- Do you usually experience urine leakage related to lifting or bending over? Currently
being treated for stress urinary incontinence with pessary/incontinence ring, pelvic
floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).