ATLAS Study: Ambulatory Treatments for Leakage Associated with Stress. Pessary versus Pelvic Floor Muscle Therapy versus Combined Therapy: A randomized Controlled Trial of Non-Surgical Treatment for Stress Urinary Incontinence
The Ambulatory Treatments for Leakage Associated with Stress Incontinence (ATLAS) Trial was a study comparing 3 non-surgical approaches to the management of stress urinary incontinence, which is involuntary urine leakage with activities such as running, coughing and sneezing. The treatments included behavioral therapy, which is the strengthening of the pelvic muscles and strategies for use of these muscles and the use of a pessary, which is a device placed into the vagina to help support the bladder neck. The third treatment approach was combination behavioral therapy and pessary use. The primary outcome time-point was 3 months after randomization and measured the patient's impression of improvement and improvement of stress incontinence symptoms, both validated measures used to evaluate women undergoing treatment for incontinence. Compared to the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared to 33%, p=0.006) and scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the patient global impression of improvement (no significant difference, p=0.10). Significantly more women in the behavioral group were satisfied with treatment as compared to the pessary group (75% compared with 63%, respectively, p=0.02). Combination therapy was not significantly different from single-modality therapy. There were no differences on any outcome measures by 12 months and greater than half of all patients were satisfied in all treatment groups.
STUDY RESULTS:
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Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, Wheeler TL, Pelvic Floor Disorders Network. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. American journal of obstetrics and gynecology. 2009 May; 200(5): 580.e1-7.
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Nager CW, Richter HE, Nygaard I, Paraiso MF, Wu JM, Kenton K, Atnip SD, Spino C, Pelvic Floor Disorders Network (PFDN). Incontinence pessaries: size, POPQ measures, and successful fitting. International urogynecology journal and pelvic floor dysfunction. 2009 Sep; 20(9): 1023-8.
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Bradley CS, Rahn DD, Nygaard IE, Barber MD, Nager CW, Kenton KS, Siddiqui NY, Abel RB, Spino C, Richter HE. The questionnaire for urinary incontinence diagnosis (QUID): validity and responsiveness to change in women undergoing non-surgical therapies for treatment of stress predominant urinary incontinence. Neurourology and urodynamics. 2010 Jun; 29(5): 727-34.
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Brubaker L, Barber MD, Nygaard I, Nager CW, Varner E, Schaffer J, Visco A, Meikle S, Spino C, Pelvic Floor Disorders Network. Quantification of vaginal support: are continuous summary scores better than POPQ stage? American journal of obstetrics and gynecology. 2010 Nov; 203(5): 512.e1-6.
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Handa VL, Whitcomb E, Weidner AC, Nygaard I, Brubaker L, Bradley CS, Paraiso MF, Schaffer J, Zyczynski HM, Zhang M, Richter HE. Sexual function before and after non-surgical treatment for stress urinary incontinence. Female pelvic medicine & reconstructive surgery. 2011 ; 17(1): 30-35.
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Barber MD, Chen Z, Lukacz E, Markland A, Wai C, Brubaker L, Nygaard I, Weidner A, Janz NK, Spino C. Further validation of the short form versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). Neurourology and urodynamics. 2011 Apr; 30(4): 541-6.
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Schaffer J, Nager CW, Xiang F, Borello-France D, Bradley CS, Wu JM, Mueller E, Norton P, Paraiso MF, Zyczynski H, Richter HE. Predictors of success and satisfaction of nonsurgical therapy for stress urinary incontinence. Obstetrics and gynecology. 2012 Jul; 120(1): 91-7.
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Kenton K, Barber M, Wang L, Hsu Y, Rahn D, Whitcomb E, Amundsen C, Bradley CS, Zyczynski H, Richter HE, Pelvic Floor Disorders Network. Pelvic floor symptoms improve similarly after pessary and behavioral treatment for stress incontinence. Female pelvic medicine & reconstructive surgery. 2012 Mar; 18(2): 118-21.
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Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C, Pelvic Floor Disorders Network. Continence pessary compared with behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstetrics and gynecology. 2010 Mar; 115(3): 609-17.
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Borello-France D, Burgio KL, Goode PS, Ye W, Weidner AC, Lukacz ES, Jelovsek JE, Bradley CS, Schaffer J, Hsu Y, Kenton K, Spino C, Pelvic Floor Disorders Network. Adherence to behavioral interventions for stress incontinence: rates, barriers, and predictors. Physical therapy. 2013 Jun; 93(6): 757-73.
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Read more about this study at clinicaltrials.gov.