Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Stress, Surgery
Brief 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.
Interventions
PROCEDUREretropubic mid-urethral sling (TVT)
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.
PROCEDUREtransobturator mid-urethral sling (TVT-O and the Monarc)
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.
Sponsors
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Treatment Success at 12 Months | 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. |
| Subjective Treatment Success at 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction at 12 Months | Follow-Up | 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. |
| Change in Quality of Life From Baseline to 12 Months | Baseline - 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). |
| Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months | 12 months | Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months) |
Countries
United States
Participant flow
Recruitment details
Recruitment took place between April 2006 and June 2008. Patients were recruited from nine clinical sites. TOMUS (Trial Of Mid-Urethral Slings) was conducted by the Urinary Incontinence Treatment Network (UITN), a cooperative network consisting of urologists and urogynecologists at 9 clinical centers and a biostatistical coordinating center.
Pre-assignment details
3521 women were screened for eligibility. 1513 did not meet inclusion criteria; 1259 were eligible for inclusion in the study but were excluded (1001 declined to participate, 258 excluded for administrative reasons). 749 women provided written consent; of these 152 were excluded (63 ineligible, 66 withdrew consent, 23 administrative reasons).
Participants by arm
| Arm | Count |
|---|---|
| Retropubic (RMUS) retropubic mid-urethral sling (TVT) | 298 |
| Transobturator (TMUS) transobturator mid-urethral sling (TVT-O and the Monarc) | 299 |
| Total | 597 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 14 |
Baseline characteristics
| Characteristic | Retropubic (RMUS) | Transobturator (TMUS) | Total |
|---|---|---|---|
| Age, Continuous | 52.7 Yrs STANDARD_DEVIATION 10.5 | 53.1 Yrs STANDARD_DEVIATION 11.5 | 52.9 Yrs STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 298 participants | 299 participants | 597 participants |
| Sex: Female, Male Female | 298 Participants | 299 Participants | 597 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 298 | 89 / 299 |
| serious Total, serious adverse events | 41 / 298 | 19 / 299 |
Outcome results
Primary
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
Population: Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 and n=292 in RMUS, TMUS, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retropubic (RMUS) | Objective Treatment Success at 12 Months | 80.8 percentage of participants |
| Transobturator (TMUS) | Objective Treatment Success at 12 Months | 77.7 percentage of participants |
Comparison: With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.95% CI: [-3.6, 9.6]
Primary
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
Population: Because the study was designed as an equivalence trial, the outcome was assessed only in women treated per-protocol (n=291 in the Retropubic arm and n=292 in the transobturator arm).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retropubic (RMUS) | Subjective Treatment Success at 12 Months | 62.2 percentage of participants |
| Transobturator (TMUS) | Subjective Treatment Success at 12 Months | 55.8 percentage of participants |
Comparison: With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.95% CI: [-1.6, 14.3]
Secondary
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Urogenital Distress Inventory (UDI) scores range from 0 to 300 with higher scores indicating greater distress. Scores are changes from baseline to the 12 month visit (baseline - 12 months)
Time frame: 12 months
Population: This is the number of participants who had complete UDI information at the 12 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retropubic (RMUS) | Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months | 106.7 units on a scale | Standard Deviation 48 |
| Transobturator (TMUS) | Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months | 110.3 units on a scale | Standard Deviation 51.2 |
Comparison: The UDI measure was compared using a two-sample t test.p-value: 0.41t-test, 2 sided
Secondary
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
Population: These are the number of patients with available quality of life data at the 12 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retropubic (RMUS) | Change in Quality of Life From Baseline to 12 Months | 126.8 units on a scale | Standard Deviation 94.5 |
| Transobturator (TMUS) | Change in Quality of Life From Baseline to 12 Months | 132.9 units on a scale | Standard Deviation 97.8 |
Comparison: The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.p-value: 0.47t-test, 2 sided
Secondary
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
Population: This is the number of women who answered the satisfaction questions at the 12 month visit (n=280 attended the 12 month visit in the retropubic arm and n=285 in the transobturator arm)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Retropubic (RMUS) | Patient Satisfaction at 12 Months | 85.9 percentage of participants analyzed |
| Transobturator (TMUS) | Patient Satisfaction at 12 Months | 90.0 percentage of participants analyzed |
Comparison: Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.p-value: 0.14Chi-squared