TOMUS-Trial Of Mid-Urethral Slings

Carelon Research

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Procedure: transobturator mid-urethral sling (TVT-O and the Monarc); Procedure: retropubic mid-urethral sling (TVT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00325039

DK58229

Details and patient eligibility

About

The primary aim of this clinical trial is to compare treatment success for two minimally invasive surgical procedures to treat stress urinary incontinence in women. These procedures are called mid-urethral slings. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and the need for other treatments(s) after surgery. Follow-up will be a minimum of two years.

Enrollment: 597 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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597 participants in 2 patient groups

1

Active Comparator group

Description:

retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)

Treatment:

Procedure: retropubic mid-urethral sling (TVT)

2

Active Comparator group

Description:

transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").

Treatment:

Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)