TY - JOUR
T1 - The trial of mid-urethral slings (TOMUS)
T2 - Design and methodology
AU - Albo, Michael E.
AU - Steers, William
AU - Diokno, Ananias
AU - Khandwala, Salil
AU - Brubaker, Linda
AU - FitzGerald, Mary Pat
AU - Richter, Holly E.
AU - Lloyd, L. Keith
AU - Albo, Michael
AU - Nager, Charles
AU - Chai, Toby
AU - Johnson, Harry W.
AU - Zyczynski, Halina M.
AU - Leng, Wendy
AU - Zimmern, Philippe
AU - Lemack, Gary
AU - Kraus, Stephen
AU - Rozanski, Thomas
AU - Norton, Peggy
AU - Kerr, Lindsey
AU - Tennstedt, Sharon
AU - Stoddard, Anne
AU - Chang, Debuene
AU - Kusek, John W.
AU - Nyberg, Leroy M.
AU - Weber, Anne M.
PY - 2008
Y1 - 2008
N2 - Objective: Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS). Patients and Methods: The primary aims of this randomized controlled trial are to compare subjective and objective success rates for urinary incontinence (UI) at 12 and 24 months following retropubic and transobturator MUS procedures. Secondary aims are to compare the resolution of overall and stress-specific UI, morbidity, the time to adequate voiding, satisfaction, and quality of life in the 2 groups. TOMUS will also assess the clinical utility of pre-operative urodynamics in women undergoing MUS procedures. The primary outcome will be obtained at 12 months and 24 months. The definition of treatment suc cess is 2-fold. Objective treatment success is defined by a negative stress test, a negative 24-hour pad test, and no retreatment for SUI. Subjective treatment success is defined by no self-reported leakage in a 3-day diary, no self-reported SUI symptoms, and no retreatment for SUI. Enrollment began April 2006 and is expected to be complete in 2 years. Conclusions: The TOMUS trial is designed to provide outcome and safety information to pelvic surgeons and their patients on the 2 most commonly performed MUS techniques.
AB - Objective: Mid-urethral slings (MUS) are increasingly common surgical procedures for the treatment of stress urinary incontinence (SUI) in women. There are currently no adequately powered trials with sufficient length of follow-up comparing the efficacy or safety of the transobturator and retropubic MUS. As a result, no selection criteria are available to guide surgeons or patients. This article describes the methodology and rationale for the Trial Of Mid-Urethral Slings (TOMUS). Patients and Methods: The primary aims of this randomized controlled trial are to compare subjective and objective success rates for urinary incontinence (UI) at 12 and 24 months following retropubic and transobturator MUS procedures. Secondary aims are to compare the resolution of overall and stress-specific UI, morbidity, the time to adequate voiding, satisfaction, and quality of life in the 2 groups. TOMUS will also assess the clinical utility of pre-operative urodynamics in women undergoing MUS procedures. The primary outcome will be obtained at 12 months and 24 months. The definition of treatment suc cess is 2-fold. Objective treatment success is defined by a negative stress test, a negative 24-hour pad test, and no retreatment for SUI. Subjective treatment success is defined by no self-reported leakage in a 3-day diary, no self-reported SUI symptoms, and no retreatment for SUI. Enrollment began April 2006 and is expected to be complete in 2 years. Conclusions: The TOMUS trial is designed to provide outcome and safety information to pelvic surgeons and their patients on the 2 most commonly performed MUS techniques.
KW - Mid-urethral sling
KW - Randomized surgical trial
KW - Tension-free vaginal sling
KW - Transobturator sling
KW - Urinary incontinence
KW - Urodynamics
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M3 - Article
AN - SCOPUS:42649107481
SN - 1537-064X
VL - 8
SP - 1
EP - 13
JO - Journal of Applied Research
JF - Journal of Applied Research
IS - 1
ER -