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TOMUS-Trial Of Mid-Urethral Slings (TOMUS)

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ClinicalTrials.gov Identifier: NCT00325039
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : September 27, 2012
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
New England Research Institutes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Incontinence
Interventions Procedure: retropubic mid-urethral sling (TVT)
Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
Enrollment 597
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).
Arm/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description retropubic mid-urethral sling (TVT) transobturator mid-urethral sling (TVT-O and the Monarc)
Period Title: Overall Study
Started 298 299
Completed 280 285
Not Completed 18 14
Reason Not Completed
Lost to Follow-up             18             14
Arm/Group Title Retropubic (RMUS) Transobturator (TMUS) Total
Hide Arm/Group Description retropubic mid-urethral sling (TVT) transobturator mid-urethral sling (TVT-O and the Monarc) Total of all reporting groups
Overall Number of Baseline Participants 298 299 597
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Yrs
Number Analyzed 298 participants 299 participants 597 participants
52.7  (10.5) 53.1  (11.5) 52.9  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants 299 participants 597 participants
Female
298
 100.0%
299
 100.0%
597
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 298 participants 299 participants 597 participants
298 299 597
1.Primary Outcome
Title Objective Treatment Success at 12 Months
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description:
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Number of Participants Analyzed 291 292
Measure Type: Number
Unit of Measure: percentage of participants
80.8 77.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retropubic (RMUS), Transobturator (TMUS)
Comments 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.
Method of Estimation Estimation Parameter difference in success rate (RMUS-TMUS)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-3.6 to 9.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Subjective Treatment Success at 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description:
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Number of Participants Analyzed 291 292
Measure Type: Number
Unit of Measure: percentage of participants
62.2 55.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retropubic (RMUS), Transobturator (TMUS)
Comments 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.
Method of Estimation Estimation Parameter difference in success (RMUS - TMUS)
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-1.6 to 14.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Patient Satisfaction at 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description:
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Number of Participants Analyzed 262 261
Measure Type: Number
Unit of Measure: percentage of participants analyzed
85.9 90.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retropubic (RMUS), Transobturator (TMUS)
Comments Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -4.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Quality of Life From Baseline to 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
These are the number of patients with available quality of life data at the 12 month visit.
Arm/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description:
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Number of Participants Analyzed 264 263
Mean (Standard Deviation)
Unit of Measure: units on a scale
126.8  (94.5) 132.9  (97.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retropubic (RMUS), Transobturator (TMUS)
Comments The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This is the number of participants who had complete UDI information at the 12 month visit.
Arm/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description:
retropubic mid-urethral sling (TVT)
transobturator mid-urethral sling (TVT-O and the Monarc)
Overall Number of Participants Analyzed 264 263
Mean (Standard Deviation)
Unit of Measure: units on a scale
106.7  (48.0) 110.3  (51.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Retropubic (RMUS), Transobturator (TMUS)
Comments The UDI measure was compared using a two-sample t test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Retropubic (RMUS) Transobturator (TMUS)
Hide Arm/Group Description retropubic mid-urethral sling (TVT) transobturator mid-urethral sling (TVT-O and the Monarc)
All-Cause Mortality
Retropubic (RMUS) Transobturator (TMUS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Retropubic (RMUS) Transobturator (TMUS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/298 (13.76%)      19/299 (6.35%)    
Blood and lymphatic system disorders     
Postoperative bleeding *  1/298 (0.34%)  1 0/299 (0.00%)  0
Nervous system disorders     
Neurologic symptoms *  1/298 (0.34%)  1 0/299 (0.00%)  0
Renal and urinary disorders     
Urethral perforation *  1/298 (0.34%)  1 0/299 (0.00%)  0
Recurrent cystitis, leading to diagnostic cystoscopy *  1/298 (0.34%)  1 0/299 (0.00%)  0
Voiding dysfunction requiring surgery, use of catheter or both *  8/298 (2.68%)  9 0/299 (0.00%)  0
Surgical and medical procedures     
Mesh exposure *  9/298 (3.02%)  10 5/299 (1.67%)  5
Mesh erosion *  1/298 (0.34%)  1 1/299 (0.33%)  1
Surgical site infection *  0/298 (0.00%)  0 2/299 (0.67%)  2
Granulation tissue *  0/298 (0.00%)  0 1/299 (0.33%)  1
Bladder perforation *  15/298 (5.03%)  15 0/299 (0.00%)  0
Vaginal epithelial perforation *  6/298 (2.01%)  6 13/299 (4.35%)  13
Urothelial abrasion *  0/298 (0.00%)  0 1/299 (0.33%)  1
Vascular disorders     
Pulmonary embolus *  0/298 (0.00%)  0 1/299 (0.33%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Retropubic (RMUS) Transobturator (TMUS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   110/298 (36.91%)      89/299 (29.77%)    
General disorders     
Self-reported pain 6 or more weeks after procedure *  7/298 (2.35%)  7 6/299 (2.01%)  7
Thrush *  1/298 (0.34%)  1 0/299 (0.00%)  0
Medication reaction *  0/298 (0.00%)  0 1/299 (0.33%)  1
Skin irritation *  0/298 (0.00%)  0 1/299 (0.33%)  1
Bilateral leg pain *  0/298 (0.00%)  0 1/299 (0.33%)  1
Decreased bladder sensation *  1/298 (0.34%)  1 0/299 (0.00%)  0
Nervous system disorders     
Neurologic symptom of numbness *  6/298 (2.01%)  8 7/299 (2.34%)  9
Neurologic symptom of weakness *  7/298 (2.35%)  7 21/299 (7.02%)  22
Psychiatric disorders     
Anxiety *  1/298 (0.34%)  1 0/299 (0.00%)  0
Renal and urinary disorders     
Genitourinary *  40/298 (13.42%)  46 24/299 (8.03%)  27
Voiding dysfunction *  10/298 (3.36%)  16 4/299 (1.34%)  5
New urge incontinence *  0/298 (0.00%)  0 1/299 (0.33%)  1
Persistent urge incontinence *  36/298 (12.08%)  54 30/299 (10.03%)  55
Sac in pelvis (seroma) *  0/298 (0.00%)  0 1/299 (0.33%)  1
Surgical and medical procedures     
Mesh exposure *  4/298 (1.34%)  4 3/299 (1.00%)  3
Surgical site infection *  2/298 (0.67%)  2 2/299 (0.67%)  2
Granulation tissue *  2/298 (0.67%)  2 2/299 (0.67%)  2
Wound edge separation *  1/298 (0.34%)  1 0/299 (0.00%)  0
Minor wound *  1/298 (0.34%)  1 0/299 (0.00%)  0
Vascular disorders     
Vascular or hematologic *  18/298 (6.04%)  20 7/299 (2.34%)  7
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Litman, PhD
Organization: New England Research Institutes, Inc.
Phone: 617 972 3297
EMail: hlitman@neriscience.com
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00325039     History of Changes
Other Study ID Numbers: DK58229
First Submitted: May 10, 2006
First Posted: May 11, 2006
Results First Submitted: March 26, 2012
Results First Posted: September 27, 2012
Last Update Posted: January 14, 2014