TOMUS-Trial Of Mid-Urethral Slings

Carelon Research597 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

597

Conditions

Urinary Incontinence

Interventions

retropubic mid-urethral sling (TVT)PROCEDURE

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.

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

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.

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

University of Alabama

Birmingham, Alabama, United States

University of California

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

Outcomes

Primary Outcomes

Objective Treatment Success at 12 Months

Objective treatment success: negative stress test, negative pad test, and no retreatment for stress urinary incontinence (SUI) including behavioral, pharmacologic or surgical procedures A provocative stress test standardized to volume and position is performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough is a positive test; a negative test indicates no urine loss. Pad testing quantifies the amount of urine involuntarily lost and is used to reflect everyday incontinence; it is negative if loss is \<15g/24 hrs.

Time frame: 12 months

Subjective Treatment Success at 12 Months

Absence of self-reported symptoms of stress-type urinary incontinence, as assessed with the use of the Medical, Epidemiological and Social Aspects of Aging (MESA) questionnaire (responded never to all 9 MESA questions), no leakage recorded in a 3-day voiding diary and no retreatment for stress incontinence including behavioral, pharmacologic or surgical treatment.

Time frame: 12 months

Secondary Outcomes

Patient Satisfaction at 12 Months

Patient satisfaction was assessed at the 12 month visit with the questions, "how satisfied or dissatisfied are you with the result of bladder surgery related to urine leakage?" Possible responses were completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. Completely and mostly satisfied were reported as "satisfied" and neutral, most dissatisfied and completely dissatisfied as "not satisfied".

Time frame: Follow-Up

Change in Quality of Life From Baseline to 12 Months

Scores on the Incontinence Impact Questionnaire range from 0 to 400 with higher scores indicating greater impact. The scores are changes from baseline to the 12 month visit (baseline - 12 months).

Time frame: Baseline - 12 months

Data from ClinicalTrials.gov

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