Urinary IncontinencePhase 4TOMUSNCT00325039

TOMUS-Trial Of Mid-Urethral Slings

A Phase 4 study testing retropubic mid-urethral sling (TVT) and transobturator mid-urethral sling (TVT-O and the Monarc) in people with Urinary Incontinence, run by Carelon Research at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Urinary Incontinence
What is being tested?: retropubic mid-urethral sling (TVT) and transobturator mid-urethral sling (TVT-O and the Monarc)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 597 participants
Where: 11 sitesUnited States
Study dates: Apr 2006to Jun 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 13Show fewer

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

Who cannot join

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)

Show all 15Show fewer

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University of Maryland
Baltimore, Maryland, 21201
University of Alabama
Birmingham, Alabama, 35294
University of Texas Southwestern
Dallas, Texas, 75390
Oakwood Hospital/Cancer Center
Dearborn, Michigan, 48123
Loyola University Medical Center
Maywood, Illinois, 60153
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
William Beaumont Hospital
Royal Oak, Michigan, 48123
University of Utah
Salt Lake City, Utah, 84132
University of Texas Health Sciences Center
San Antonio, Texas, 78229-3900
University of California
San Diego, California, 92103
Kaiser Permanente
San Diego, California, 92110

Other trials in United States

About this study

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.

Conditions: Urinary Incontinence
Being tested: retropubic mid-urethral sling (TVT), transobturator mid-urethral sling (TVT-O and the Monarc)
Keywords: Urinary Incontinence, Stress, Surgery
Medical subject headings: Urinary Incontinence, Urinary Incontinence, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

retropubic mid-urethral sling (TVT)Procedure or surgery
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 or surgery
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 groups in NCT00325039
Study group	Role	What they receive
1	Active comparator	retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare) Receives: Procedure: retropubic mid-urethral sling (TVT)
2	Active comparator	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"). Receives: Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 months

Secondary outcomes (3)

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".
Measured: 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).
Measured: Baseline - 12 months
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)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jun 2013

First posted11 May 2006 (estimated)
Study startApr 2006
Primary completionJun 2010
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 597 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00325039
Sponsor's protocol ID: DK58229
Acronym: TOMUS
Status last verified: Dec 2013
First submitted: 10 May 2006
Last updated: 14 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chai TC, Huang L, Kenton K, Richter HE, Baker J, Kraus S, Litman H; Urinary Incontinence Treatment Network (UITN). Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery. Neurourol Urodyn. 2012 Apr;31(4):496-501. doi: 10.1002/nau.21198. Epub 2012 Feb 29.
PubMed 22378483
Nygaard I, Brubaker L, Chai TC, Markland AD, Menefee SA, Sirls L, Sutkin G, Zimmern P, Arisco A, Huang L, Tennstedt S, Stoddard A. Risk factors for urinary tract infection following incontinence surgery. Int Urogynecol J. 2011 Oct;22(10):1255-65. doi: 10.1007/s00192-011-1429-9. Epub 2011 May 11.
PubMed 21560012
Richter HE, Litman HJ, Lukacz ES, Sirls LT, Rickey L, Norton P, Lemack GE, Kraus S, Moalli P, Fitzgerald MP, Dandreo KJ, Huang L, Kusek JW; Urinary Incontinence Treatment Network. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol. 2011 Apr;117(4):913-921. doi: 10.1097/AOG.0b013e31820f3892.
PubMed 21422865
Chai TC, Kenton K, Xu Y, Sirls L, Zyczynski H, Wilson TS, Rahn DD, Whitcomb EL, Hsu Y, Gormley EA. Effects of concomitant surgeries during midurethral slings (MUS) on postoperative complications, voiding dysfunction, continence outcomes, and urodynamic variables. Urology. 2012 Jun;79(6):1256-61. doi: 10.1016/j.urology.2012.02.048. Epub 2012 Apr 25.
PubMed 22542356
Brubaker L, Norton PA, Albo ME, Chai TC, Dandreo KJ, Lloyd KL, Lowder JL, Sirls LT, Lemack GE, Arisco AM, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol. 2011 Nov;205(5):498.e1-6. doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20.
PubMed 21925636
Nager CW, Sirls L, Litman HJ, Richter H, Nygaard I, Chai T, Kraus S, Zyczynski H, Kenton K, Huang L, Kusek J, Lemack G; Urinary Incontinence Treatment Network. Baseline urodynamic predictors of treatment failure 1 year after mid urethral sling surgery. J Urol. 2011 Aug;186(2):597-603. doi: 10.1016/j.juro.2011.03.105. Epub 2011 Jun 16.
PubMed 21683412
Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
PubMed 24772006
Brubaker L, Rickey L, Xu Y, Markland A, Lemack G, Ghetti C, Kahn MA, Nagaraju P, Norton P, Chang TD, Stoddard A; Urinary Incontinence Treatment Network. Symptoms of combined prolapse and urinary incontinence in large surgical cohorts. Obstet Gynecol. 2010 Feb;115(2 Pt 1):310-316. doi: 10.1097/AOG.0b013e3181cb86b2.
PubMed 20093904
Nager CW, Kraus SR, Kenton K, Sirls L, Chai TC, Wai C, Sutkin G, Leng W, Litman H, Huang L, Tennstedt S, Richter HE; Urinary Incontinence Treatment Network. Urodynamics, the supine empty bladder stress test, and incontinence severity. Neurourol Urodyn. 2010 Sep;29(7):1306-11. doi: 10.1002/nau.20836.
PubMed 20127832
Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17.
PubMed 20479459
Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai TC, Lemack G, Sirls L, Dandreo KJ, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life. J Urol. 2010 Feb;183(2):622-8. doi: 10.1016/j.juro.2009.09.083. Epub 2009 Dec 16.
PubMed 20018326
Sirls LT, Tennstedt S, Albo M, Chai T, Kenton K, Huang L, Stoddard AM, Arisco A, Gormley EA. Factors associated with quality of life in women undergoing surgery for stress urinary incontinence. J Urol. 2010 Dec;184(6):2411-5. doi: 10.1016/j.juro.2010.08.019. Epub 2010 Oct 16.
PubMed 20952014
Brubaker L, Litman HJ, Kim HY, Zimmern P, Dyer K, Kusek JW, Richter HE, Stoddard A; Urinary Incontinence Treatment Network. Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J. 2015 Aug;26(8):1155-9. doi: 10.1007/s00192-015-2661-5. Epub 2015 Mar 24.
PubMed 25800900
Wai CY, Curto TM, Zyczynski HM, Stoddard AM, Burgio KL, Brubaker L, Rickey LM, Menefee SA; Urinary Incontinence Treatment Network*. Patient satisfaction after midurethral sling surgery for stress urinary incontinence. Obstet Gynecol. 2013 May;121(5):1009-1016. doi: 10.1097/AOG.0b013e31828ca49e.
PubMed 23635737

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TOMUS-Trial Of Mid-Urethral Slings
ClinicalTrials.gov ID: NCT00325039
Acronym / sponsor ID: TOMUS / DK58229
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence, Stress, Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 597 participants (actual)
Lead sponsor: Carelon ResearchUniversity, hospital or other
Study start: Apr 2006
Primary completion: Jun 2010 (actual)
Study completion: Jun 2013 (actual)
First posted: 11 May 2006 (estimated)
Results: Posted 27 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Procedure: retropubic mid-urethral sling (TVT)retropubic mid-urethral sling (TVT) The specific TVT used was the Tension-free Vaginal Tape (Gynecare)
2	Active comparator	Procedure: transobturator mid-urethral sling (TVT-O and the Monarc)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").

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (15 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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 or surgery	1
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.	Procedure or surgery	2

Primary outcome

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.

3 secondary outcomes

Patient Satisfaction at 12 Months
Time frame: Follow-Up
Change in Quality of Life From Baseline to 12 Months
Time frame: Baseline - 12 months
Bother as Measured by the Urogenital Distress Inventory (UDI) at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 27 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Retropubic (RMUS)	298	280
Transobturator (TMUS)	299	285

Primary outcome: Objective Treatment Success at 12 Months

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Retropubic (RMUS) n = 291	Transobturator (TMUS) n = 292
Value	80.8	77.7

Retropubic (RMUS) vs Transobturator (TMUS): difference in success rate (RMUS-TMUS): 3.0 (95% CI -3.6 to 9.6)

Population analysed: 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).

Primary outcome: Subjective Treatment Success at 12 Months

Time frame: 12 months. Number. Unit: percentage of participants

Measure	Retropubic (RMUS) n = 291	Transobturator (TMUS) n = 292
Value	62.2	55.8

Retropubic (RMUS) vs Transobturator (TMUS): difference in success (RMUS - TMUS): 6.4 (95% CI -1.6 to 14.3)

Population analysed: 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).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Consistent with the primary outcome reported at 12 months, adverse event data through the 12 month visit are reported here.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Retropubic (RMUS)	41 of 298 (13.8%)	110 of 298 (36.9%)	Not reported
Transobturator (TMUS)	19 of 299 (6.4%)	89 of 299 (29.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22378483Chai TC, Huang L, Kenton K, Richter HE, Baker J, Kraus S, Litman H; Urinary Incontinence Treatment Network (UITN). Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery. Neurourol Urodyn. 2012 Apr;31(4):496-501. doi: 10.1002/nau.21198. Epub 2012 Feb 29.
Background: PubMed 21560012Nygaard I, Brubaker L, Chai TC, Markland AD, Menefee SA, Sirls L, Sutkin G, Zimmern P, Arisco A, Huang L, Tennstedt S, Stoddard A. Risk factors for urinary tract infection following incontinence surgery. Int Urogynecol J. 2011 Oct;22(10):1255-65. doi: 10.1007/s00192-011-1429-9. Epub 2011 May 11.
Background: PubMed 21422865Richter HE, Litman HJ, Lukacz ES, Sirls LT, Rickey L, Norton P, Lemack GE, Kraus S, Moalli P, Fitzgerald MP, Dandreo KJ, Huang L, Kusek JW; Urinary Incontinence Treatment Network. Demographic and clinical predictors of treatment failure one year after midurethral sling surgery. Obstet Gynecol. 2011 Apr;117(4):913-921. doi: 10.1097/AOG.0b013e31820f3892.
Background: PubMed 22542356Chai TC, Kenton K, Xu Y, Sirls L, Zyczynski H, Wilson TS, Rahn DD, Whitcomb EL, Hsu Y, Gormley EA. Effects of concomitant surgeries during midurethral slings (MUS) on postoperative complications, voiding dysfunction, continence outcomes, and urodynamic variables. Urology. 2012 Jun;79(6):1256-61. doi: 10.1016/j.urology.2012.02.048. Epub 2012 Apr 25.
Background: PubMed 21925636Brubaker L, Norton PA, Albo ME, Chai TC, Dandreo KJ, Lloyd KL, Lowder JL, Sirls LT, Lemack GE, Arisco AM, Xu Y, Kusek JW; Urinary Incontinence Treatment Network. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obstet Gynecol. 2011 Nov;205(5):498.e1-6. doi: 10.1016/j.ajog.2011.07.011. Epub 2011 Jul 20.
Background: PubMed 21683412Nager CW, Sirls L, Litman HJ, Richter H, Nygaard I, Chai T, Kraus S, Zyczynski H, Kenton K, Huang L, Kusek J, Lemack G; Urinary Incontinence Treatment Network. Baseline urodynamic predictors of treatment failure 1 year after mid urethral sling surgery. J Urol. 2011 Aug;186(2):597-603. doi: 10.1016/j.juro.2011.03.105. Epub 2011 Jun 16.
Results publication: PubMed 24772006Urinary Incontinence Treatment Network (UITN). The Trial of Mid-Urethral Slings (TOMUS): Design and Methodology. J Appl Res. 2008;8(1):AlboVol8No1.
Results publication: PubMed 20093904Brubaker L, Rickey L, Xu Y, Markland A, Lemack G, Ghetti C, Kahn MA, Nagaraju P, Norton P, Chang TD, Stoddard A; Urinary Incontinence Treatment Network. Symptoms of combined prolapse and urinary incontinence in large surgical cohorts. Obstet Gynecol. 2010 Feb;115(2 Pt 1):310-316. doi: 10.1097/AOG.0b013e3181cb86b2.
Results publication: PubMed 20127832Nager CW, Kraus SR, Kenton K, Sirls L, Chai TC, Wai C, Sutkin G, Leng W, Litman H, Huang L, Tennstedt S, Richter HE; Urinary Incontinence Treatment Network. Urodynamics, the supine empty bladder stress test, and incontinence severity. Neurourol Urodyn. 2010 Sep;29(7):1306-11. doi: 10.1002/nau.20836.
Results publication: PubMed 20479459Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17.
Results publication: PubMed 20018326Richter HE, Kenton K, Huang L, Nygaard I, Kraus S, Whitcomb E, Chai TC, Lemack G, Sirls L, Dandreo KJ, Stoddard A. The impact of obesity on urinary incontinence symptoms, severity, urodynamic characteristics and quality of life. J Urol. 2010 Feb;183(2):622-8. doi: 10.1016/j.juro.2009.09.083. Epub 2009 Dec 16.
Results publication: PubMed 20952014Sirls LT, Tennstedt S, Albo M, Chai T, Kenton K, Huang L, Stoddard AM, Arisco A, Gormley EA. Factors associated with quality of life in women undergoing surgery for stress urinary incontinence. J Urol. 2010 Dec;184(6):2411-5. doi: 10.1016/j.juro.2010.08.019. Epub 2010 Oct 16.
Urinary Incontinence Treatment Network Public WebsiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ann Gormley, M.D. study chair

Dartmouth-Hitchcock Medical Center

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Treatment Success at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00325039, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.