TOMUS-Trial Of Mid-Urethral Slings

Inclusion Criteria:

- Female

- Stress urinary incontinence (SUI) as evidenced by all of the following:

- Self-reported stress-type urinary incontinence symptoms, of duration ≥ 3 months

- Medical, Epidemiological and Social Aspects of Aging (MESA) stress symptom score
(percent of total possible stress score) greater than MESA urge symptom score
(percent of total possible urge score)

- Observation of leakage by provocative stress test at a bladder volume ≤ 300ml

- Bladder capacity ≥ 200ml by stress test

- Post-void residual (PVR) ≤ 100cc with pelvic organ prolapse (POP) Stage I or lower.
If POP is Stage II-IV, PVR >100cc but ≤ 500cc is allowed

- Eligible for both retropubic and transobturator procedures

- No medical contraindications, e.g., current urinary tract infection (UTI), history of
pelvic irradiation, history of lower urinary tract cancer

- American Society of Anesthesiologists (ASA) class I, II, or III

- No current intermittent catheterization

- Available for 24-months of follow-up and able to complete study assessments, per
clinician judgment

- Signed consent form

Exclusion Criteria:

- Age <21 years

- Non-ambulatory (ambulatory with assistive devices does not exclude the patient)

- Pregnancy by self-report or positive pregnancy test, or self-reported intention to
ever become pregnant

- Current chemotherapy or current or history of pelvic radiation therapy

- Systemic disease known to affect bladder function (i.e., Parkinson's disease,
multiple sclerosis, spina bifida, spinal cord injury or trauma)

- Urethral diverticulum, current or previous (i.e. repaired)

- Prior augmentation cystoplasty or artificial sphincter

- Implanted nerve stimulators for urinary symptoms

- History of synthetic sling for stress urinary incontinence

- <12 months post-partum

- Laparoscopic or open pelvic surgery <3 months*

- Current evaluation or treatment for chronic pelvic pain (painful bladder syndrome)

- Participation in another treatment intervention trial that might influence the
results of this trial

- Need for concomitant surgery requiring an abdominal incision, use of graft material
in the anterior compartment, or any use of synthetic graft material

- Enrollment in other urinary incontinence trials including SISTEr/E-SISTEr or
BE-DRI/E-BE-DRI