The trial of mid-urethral slings (TOMUS)

Design and methodology

Michael E. Albo, William Steers, Ananias Diokno, Salil Khandwala, Linda Brubaker, Mary Pat FitzGerald, Holly E. Richter, L. Keith Lloyd, Michael Albo, Charles Nager, Toby Chai, Harry W. Johnson, Halina M. Zyczynski, Wendy Leng, Philippe Zimmern, Gary Lemack, Stephen Kraus, Thomas Rozanski, Peggy Norton, Lindsey Kerr & 6 others Sharon Tennstedt, Anne Stoddard, Debuene Chang, John W. Kusek, Leroy M. Nyberg, Anne M. Weber

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-13
Number of pages13
JournalJournal of Applied Research
Volume8
Issue number1
StatePublished - 2008

Fingerprint

Suburethral Slings
Stress Urinary Incontinence
Retreatment
Safety
Urodynamics
Urinary Incontinence
Therapeutics
Exercise Test
Patient Selection
Randomized Controlled Trials
Quality of Life
Morbidity

Keywords

  • Mid-urethral sling
  • Randomized surgical trial
  • Tension-free vaginal sling
  • Transobturator sling
  • Urinary incontinence
  • Urodynamics

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

Albo, M. E., Steers, W., Diokno, A., Khandwala, S., Brubaker, L., FitzGerald, M. P., ... Weber, A. M. (2008). The trial of mid-urethral slings (TOMUS): Design and methodology. Journal of Applied Research, 8(1), 1-13.

The trial of mid-urethral slings (TOMUS) : Design and methodology. / Albo, Michael E.; Steers, William; Diokno, Ananias; Khandwala, Salil; Brubaker, Linda; FitzGerald, Mary Pat; Richter, Holly E.; Lloyd, L. Keith; Albo, Michael; Nager, Charles; Chai, Toby; Johnson, Harry W.; Zyczynski, Halina M.; Leng, Wendy; Zimmern, Philippe; Lemack, Gary; Kraus, Stephen; Rozanski, Thomas; Norton, Peggy; Kerr, Lindsey; Tennstedt, Sharon; Stoddard, Anne; Chang, Debuene; Kusek, John W.; Nyberg, Leroy M.; Weber, Anne M.

In: Journal of Applied Research, Vol. 8, No. 1, 2008, p. 1-13.

Research output: Contribution to journalArticle

Albo, ME, Steers, W, Diokno, A, Khandwala, S, Brubaker, L, FitzGerald, MP, Richter, HE, Lloyd, LK, Albo, M, Nager, C, Chai, T, Johnson, HW, Zyczynski, HM, Leng, W, Zimmern, P, Lemack, G, Kraus, S, Rozanski, T, Norton, P, Kerr, L, Tennstedt, S, Stoddard, A, Chang, D, Kusek, JW, Nyberg, LM & Weber, AM 2008, 'The trial of mid-urethral slings (TOMUS): Design and methodology', Journal of Applied Research, vol. 8, no. 1, pp. 1-13.
Albo ME, Steers W, Diokno A, Khandwala S, Brubaker L, FitzGerald MP et al. The trial of mid-urethral slings (TOMUS): Design and methodology. Journal of Applied Research. 2008;8(1):1-13.
Albo, Michael E. ; Steers, William ; Diokno, Ananias ; Khandwala, Salil ; Brubaker, Linda ; FitzGerald, Mary Pat ; Richter, Holly E. ; Lloyd, L. Keith ; Albo, Michael ; Nager, Charles ; Chai, Toby ; Johnson, Harry W. ; Zyczynski, Halina M. ; Leng, Wendy ; Zimmern, Philippe ; Lemack, Gary ; Kraus, Stephen ; Rozanski, Thomas ; Norton, Peggy ; Kerr, Lindsey ; Tennstedt, Sharon ; Stoddard, Anne ; Chang, Debuene ; Kusek, John W. ; Nyberg, Leroy M. ; Weber, Anne M. / The trial of mid-urethral slings (TOMUS) : Design and methodology. In: Journal of Applied Research. 2008 ; Vol. 8, No. 1. pp. 1-13.
@article{a789c8047d744c63b5dcf3fd2bade6b8,
title = "The trial of mid-urethral slings (TOMUS): Design and methodology",
abstract = "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.",
keywords = "Mid-urethral sling, Randomized surgical trial, Tension-free vaginal sling, Transobturator sling, Urinary incontinence, Urodynamics",
author = "Albo, {Michael E.} and William Steers and Ananias Diokno and Salil Khandwala and Linda Brubaker and FitzGerald, {Mary Pat} and Richter, {Holly E.} and Lloyd, {L. Keith} and Michael Albo and Charles Nager and Toby Chai and Johnson, {Harry W.} and Zyczynski, {Halina M.} and Wendy Leng and Philippe Zimmern and Gary Lemack and Stephen Kraus and Thomas Rozanski and Peggy Norton and Lindsey Kerr and Sharon Tennstedt and Anne Stoddard and Debuene Chang and Kusek, {John W.} and Nyberg, {Leroy M.} and Weber, {Anne M.}",
year = "2008",
language = "English (US)",
volume = "8",
pages = "1--13",
journal = "Journal of Applied Research",
issn = "1537-064X",
publisher = "The Journal of Applied Research",
number = "1",

}

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

UR - http://www.scopus.com/inward/record.url?scp=42649107481&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=42649107481&partnerID=8YFLogxK

M3 - Article

VL - 8

SP - 1

EP - 13

JO - Journal of Applied Research

JF - Journal of Applied Research

SN - 1537-064X

IS - 1

ER -