TOMUS-Trial Of Mid-Urethral Slings
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Intervention: retropubic mid-urethral sling (TVT); transobturator mid-urethral sling (TVT-O and the Monarc)
Intervention description: This trial is a comparison of two types of mid-urethral slings. The retropubic mid-urethral mesh sling is used for treatment of stress incontinence; this procedure was less invasive than the fascial sling procedures that were reference standards at the start of the study. Specifically, a synthetic tape is passed transvaginally at the midurethral level through the retropubic space.; This trial is a comparison of two types of mid-urethral slings. The transobturator mid-urethral sling is used for treatment of stress incontinence; this procedure was developed to minimize the potential for bladder and bowel injuries associated with the retropubic sling, since the sling is passed through the obturator canal, avoiding the pelvic organs in the retropubic space.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 597.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Urinary Incontinence, Stress; Surgery

Summary:

      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.
    

Eligibility criteria:

        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