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Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial

Department of Obstetrics and Gynecology, Division of Women's Pelvic Medicine and Reconstructive Surgery University of Alabama at Birmingham

Kathryn L Burgio

Patricia S Goode

Birmingham/Atlanta Geriatric Research, Education and Clinical Center (GRECC), Department of Veterans Affairs Medical Center, Birmingham, AL; Division of Gerontology and Geriatric Medicine, University of Alabama at Birmingham

Diane Borello-France

Department of Physical Therapy, Duquesne University

Catherine S Bradley

Department of Obstetrics and Gynecology, University of Iowa

Linda Brubaker

Department of Obstetrics and Gynecology, Loyola University Medical Center, Maywood, IL

Victoria L Handa

Department of Obstetrics and Gynecology, Johns Hopkins School of Medicine, Baltimore, MD

Paul M Fine

Department of Obstetrics and Gynecology, Baylor College of Medicine, Houston, TX

Anthony G Visco

Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill

Halina M Zyczynski

Division of Gynecology Specialties, University of Pittsburgh

John T Wei

Department of Urology, University of Michigan

Anne M Weber

Contraception and Reproductive Health Branch, Center for Population Research, National Institute of Child Health and Human Development, National Institutes of Health

for the Pelvic Floor Disorders Network

Background Non-surgical treatment for stress urinary incontinence (SUI) is recommended as first-line therapy, yet few prospective studies and no randomized trials compare the most common non-surgical treatments for SUI.

Purpose To present the design and methodology of the ambulatory treatments for leakage associated with stress (ATLAS) trial, a randomized clinical trial comparing three interventions for predominant SUI in women: intravaginal continence pessary; behavioral therapy (including pelvic floor muscle training and exercise and bladder control strategies); and a combination of the two treatments.

Methods Treatment outcome measures, collected at 12 weeks and six and 12 months post randomization, include the Patient Global Impression of Improvement (PGI-I), the Stress Incontinence Scale of the Pelvic Floor Distress Inventory (PFDI), seven-day bladder diaries, Pelvic Floor Impact Questionnaire (PFIQ), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12), Patient Satisfaction Questionnaire (PSQ) and the Medical Outcomes Study Short Form Health Survey (SF-36).

Limitations The study design reduces most common biases, but some degree of selection bias may remain.

Conclusion This trial will provide useful information to help counsel women with stress and mixed incontinence about the relative efficacy and satisfaction with pessary, behavioral therapy and both treatments combined.

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