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

Abstract

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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References

Abrams P , Cardozo L , Fall M et al. The Standardization of terminology of lower urinary tract function: Report from the Standardisation Sub-committee of the International Continence Society . Neurourol Urodynam 2002; 21: 167–178 .

Burns PA , Pranikoff K , Nochajski TH , Hadley EC , Levy KJ , Ory MG . A comparison of effectiveness of biofeedback and pelvic muscle exercise treatment of stress incontinence in older community-dwelling women . J Gerontol 1993; 48: M-167–M-74 .

Bo K , Talseth T , Holm I . Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women . Br Med J 1999; 318: 487–493 .

Henalla SM , Hutchins CJ , Robinson P , MacVicar J . Nonoperative methods in the treatment of female genuine stress incontinence of urine . J Ob Gyn 1989; 9: 222–225 .

Berghmans LCM , Hendriks HJM , Bo K , Hay-Smith EJ , deBie RA , van Waalwijk van Doorn ESC . Conservative treatment of stress urinary incontinence in women: a systematic review of controlled clinical trials . Br J Urol 1998; 82: 181–191 .

Hay-Smith EJC , Bo K , Berghmans LCM et al. Pelvic floor muscle training for urinary incontinence in women . Cochrane Database Syst 2002; Rev 1:CD001407.

Goode PS , Burgio KL , Locher JL et al. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: A randomized control trial . JAMA 2003; 290: 345–352 .

Bhatia NN , Bergman A . Pessary test in women with urinary incontinence . Obstet Gynecol 1985; 65: 220–226 .

Palumbo MV. Pessary placement and management . Ostomy and Wound Management 2000; 46: 40–45 .

10.

Nygaard I. Prevention of exercise incontinence with mechanical devices . J Reprod Med 1995; 40: 89–94 .

11.

Wilson PD , Berghmans B , Hagen S et al. Adult conservative management. In: Abrams P , Cardozo L , Khoury S , Wein A eds. Incontinence Vol. 2. 3rd International Consultation on Incontinence 26–29 June 2004; International Continence Society , 855–964, 2005.

12.

Thom D , van den Eeden S , Ragins A et al. Differences in prevalence of urinary incontinence by race/ethnicity . J Urol 2006; 175: 259–264 .

13.

Brink CA , Sampselle CM , Wells TJ , Diokno AC , Gillis GL . A digital test for pelvic muscle strength in older women with urinary incontinence . Nurs Research 1989; 38: 196–199 .

14.

Bump RC , Mattiasson A , Bo K et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction . Am J Obstet Gynecol 1996; 175: 10–17 .

15.

Yalcin I , Bump RC . Validation of two global impression questionnaires for incontinence . Am J Obstet Gynecol 2003; 189: 98–101 .

16.

Wagner TH , Patrick DL , Bavendam TG , Martin ML , Buesching DP . Quality of life of persons with urinary incontinence: development of a new measure . Urology 1996; 47: 67–71 .

17.

Patrick DL , Martin ML , Bushnell DM , Yalcin I , Wagner TH , Buesching DP . Quality of life of women with urinary incontinence: further development of the incontinence quality of life instruction (I-QOL) . Urology 1999; 53: 71–76 .

18.

Barber MD , Kuchibhatia MN , Pieper CF , Bump RC . Psychometric evaluation of two comprehensive condition-specific quality of life instruments for women with pelvic floor disorders . Am J Obstet Gynecol 2001; 185: 1388–1395 .

19.

Ware JE Jr , Gandek B . Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) . J Clin Epidemiol 1998; 51: 903–912 .

20.

Furlong WJ , Feeny DH , Torrance GW et al. The Health Utilities Index (HUI) system for assessing health-related quality of life in clinical studies . Ann Med 2001; 33: 375–384 .

21.

Bradley CS , Rovner ES , Morgan MA et al. A new questionnaire for urinary incontinence diagnosis in women: Development and testing . Am J Obstet Gynecol 2005; 192: 66–73 .

22.

Hunskaar S , Vinsnes A . The quality of life in women with urinary incontinence as measured by the Sickness Impact Profile . JAGS 1991; 39: 378–382 .

23.

Rogers RG , Coates KW , Kammerer-Dork D , Khalsa S , Qualls C . A short form of the Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) . Intl Urogynecol J 2003; 14: 164–168 .

24.

Dennerstein L , Lehert P , Dudley E . Short scale to measure female sexuality: adapted from McCoy Female Sexuality Questionnaire . J Sex Marital Therap 2001; 27: 339–351 .

25.

Burgio KL , Goode PS , Richter HE , Roth DL . Global ratings of patient satisfaction and perceptions of improvement with treatment for urinary incontinence: Validation of three global patient ratings . Neurourol Urodyn, 2006; 25: 411–417 .

26.

Burgio KL , Locher JL , Goode PS , Hardin JM , McDowell BJ , Candib D . Behavioral versus drug treatment for urge incontinence in older women: A randomized trial . JAMA 1998; 23: 1995–2000 .

27.

Burgio KL , Goode PS , Locher JL et al. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women . JAMA 2002; 288: 2293–2299 .

28.

Wyman JF , Choi SC , Harkins SW , Wilson MS , Fantl JA . The urinary diary in evaluation of incontinent women . A test-retest analysis. Obstet Gynecol 1988; 71: 812–817 .