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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

Tracking Information
First Submitted Date  ICMJE May 10, 2006
First Posted Date  ICMJE May 11, 2006
Results First Submitted Date  ICMJE March 26, 2012
Results First Posted Date  ICMJE September 27, 2012
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • Objective Treatment Success at 12 Months [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2006)
Cure rates
Change History Complete list of historical versions of study NCT00325039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • Patient Satisfaction at 12 Months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2006)
  • Quality of Life and Symptom Bother
  • Return to Adequate Voiding
  • Patient Satisfaction with Treatment Outcome
  • Resumption of Normal Activities
  • Sexual Function
  • Complications and Morbidity
  • Costs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TOMUS-Trial Of Mid-Urethral Slings
Official Title  ICMJE TOMUS-Trial Of Mid-Urethral Slings
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • Procedure: retropubic 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.
  • Procedure: transobturator 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.
Study Arms  ICMJE
  • Active Comparator: 1
    retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
    Intervention: Procedure: retropubic mid-urethral sling (TVT)
  • Active Comparator: 2
    transobturator mid-urethral sling (TVT-O and the Monarc) Two transobturator slings were used: the Tension-free Vaginal Tape Obturator (Gynecare), which is placed starting inside the vagina and coming out through the obturator foramen ("in-to-out") or the Monarc (American Medical System), which is placed starting in the groin area, passing through the obturator foramen, and then into the vagina ("out-to-in").
    Intervention: Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2008)
597
Original Enrollment  ICMJE
 (submitted: May 10, 2006)
588
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325039
Other Study ID Numbers  ICMJE DK58229
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New England Research Institutes
Study Sponsor  ICMJE New England Research Institutes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ann Gormley, M.D. Dartmouth-Hitchcock Medical Center
PRS Account New England Research Institutes
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP