Trial Outcomes & Findings for TOMUS-Trial Of Mid-Urethral Slings (NCT NCT00325039)

Last Updated: 2014-01-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

597 participants

Primary outcome timeframe

12 months

Results posted on

2014-01-14

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Retropubic (RMUS) retropubic mid-urethral sling (TVT)	Transobturator (TMUS) transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Study STARTED	298	299
Overall Study COMPLETED	280	285
Overall Study NOT COMPLETED	18	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Retropubic (RMUS) retropubic mid-urethral sling (TVT)	Transobturator (TMUS) transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Study Lost to Follow-up	18	14

Baseline Characteristics

TOMUS-Trial Of Mid-Urethral Slings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retropubic (RMUS) n=298 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=299 Participants transobturator mid-urethral sling (TVT-O and the Monarc)	Total n=597 Participants Total of all reporting groups
Age, Continuous	52.7 Yrs STANDARD_DEVIATION 10.5 • n=93 Participants	53.1 Yrs STANDARD_DEVIATION 11.5 • n=4 Participants	52.9 Yrs STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	298 Participants n=93 Participants	299 Participants n=4 Participants	597 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	298 participants n=93 Participants	299 participants n=4 Participants	597 participants n=27 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Retropubic (RMUS) n=291 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=292 Participants transobturator mid-urethral sling (TVT-O and the Monarc)
Objective Treatment Success at 12 Months	80.8 percentage of participants	77.7 percentage of participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Retropubic (RMUS) n=291 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=292 Participants transobturator mid-urethral sling (TVT-O and the Monarc)
Subjective Treatment Success at 12 Months	62.2 percentage of participants	55.8 percentage of participants

SECONDARY outcome

Timeframe: 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)

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".

Outcome measures

Outcome measures
Measure	Retropubic (RMUS) n=262 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=261 Participants transobturator mid-urethral sling (TVT-O and the Monarc)
Patient Satisfaction at 12 Months	85.9 percentage of participants analyzed	90.0 percentage of participants analyzed

SECONDARY outcome

Timeframe: Baseline - 12 months

Population: These are the number of patients with available quality of life data at the 12 month visit.

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).

Outcome measures

Outcome measures
Measure	Retropubic (RMUS) n=264 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=263 Participants transobturator mid-urethral sling (TVT-O and the Monarc)
Change in Quality of Life From Baseline to 12 Months	126.8 units on a scale Standard Deviation 94.5	132.9 units on a scale Standard Deviation 97.8

SECONDARY outcome

Timeframe: 12 months

Population: This is the number of participants who had complete UDI information at the 12 month visit.

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)

Outcome measures

Outcome measures
Measure	Retropubic (RMUS) n=264 Participants retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=263 Participants transobturator mid-urethral sling (TVT-O and the Monarc)
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months	106.7 units on a scale Standard Deviation 48.0	110.3 units on a scale Standard Deviation 51.2

Adverse Events

Retropubic (RMUS)

Serious events: 41 serious events

Other events: 110 other events

Deaths: 0 deaths

Transobturator (TMUS)

Serious events: 19 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Retropubic (RMUS) n=298 participants at risk retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=299 participants at risk transobturator mid-urethral sling (TVT-O and the Monarc)
Surgical and medical procedures Mesh exposure	3.0% 9/298 • Number of events 10 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	1.7% 5/299 • Number of events 5 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Mesh erosion	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Surgical site infection	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.67% 2/299 • Number of events 2 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Granulation tissue	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Urethral perforation	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Bladder perforation	5.0% 15/298 • Number of events 15 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Vaginal epithelial perforation	2.0% 6/298 • Number of events 6 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	4.3% 13/299 • Number of events 13 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Recurrent cystitis, leading to diagnostic cystoscopy	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Vascular disorders Pulmonary embolus	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Blood and lymphatic system disorders Postoperative bleeding	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Nervous system disorders Neurologic symptoms	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Voiding dysfunction requiring surgery, use of catheter or both	2.7% 8/298 • Number of events 9 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Urothelial abrasion	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.

Other adverse events

Additional Information

Heather Litman, PhD

New England Research Institutes, Inc.

Phone: 617 972 3297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Retropubic (RMUS) n=298 participants at risk retropubic mid-urethral sling (TVT)	Transobturator (TMUS) n=299 participants at risk transobturator mid-urethral sling (TVT-O and the Monarc)
Surgical and medical procedures Mesh exposure	1.3% 4/298 • Number of events 4 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	1.0% 3/299 • Number of events 3 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Surgical site infection	0.67% 2/298 • Number of events 2 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.67% 2/299 • Number of events 2 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Genitourinary	13.4% 40/298 • Number of events 46 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	8.0% 24/299 • Number of events 27 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Vascular disorders Vascular or hematologic	6.0% 18/298 • Number of events 20 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	2.3% 7/299 • Number of events 7 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Nervous system disorders Neurologic symptom of numbness	2.0% 6/298 • Number of events 8 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	2.3% 7/299 • Number of events 9 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Nervous system disorders Neurologic symptom of weakness	2.3% 7/298 • Number of events 7 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	7.0% 21/299 • Number of events 22 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Voiding dysfunction	3.4% 10/298 • Number of events 16 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	1.3% 4/299 • Number of events 5 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Self-reported pain 6 or more weeks after procedure	2.3% 7/298 • Number of events 7 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	2.0% 6/299 • Number of events 7 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders New urge incontinence	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Persistent urge incontinence	12.1% 36/298 • Number of events 54 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	10.0% 30/299 • Number of events 55 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Granulation tissue	0.67% 2/298 • Number of events 2 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.67% 2/299 • Number of events 2 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Psychiatric disorders Anxiety	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Thrush	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Wound edge separation	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Surgical and medical procedures Minor wound	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Medication reaction	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Skin irritation	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Renal and urinary disorders Sac in pelvis (seroma)	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Bilateral leg pain	0.00% 0/298 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.33% 1/299 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
General disorders Decreased bladder sensation	0.34% 1/298 • Number of events 1 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.	0.00% 0/299 • Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.