OBJECTIVE: The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI). METHODS:Change in symptom and condition-specific health-related quality-of-life (HRQOL) measures were compared between pessary and behavioral groups 3 months after randomization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial. Four hundred forty-six women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary, prolapse, and colorectal scales of the Pelvic Floor Distress Inventory; urinary, prolapse, and colorectal scales of the Pelvic Floor Impact Questionnaire; and Stress and Urge scales of the Questionnaire for Urinary Incontinence Diagnosis. Student t test and analysis of variance were used to compare scores within and between groups. RESULTS:Mean age of participants was 49.8 (SD, 11.9) years; 84% were white, and 10% were African American. One hundred forty-nine were randomized to pessary, and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after randomization, but there was no statistically significant difference between groups. CONCLUSIONS: There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI.
RCT Entities:
OBJECTIVE: The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women randomized to pessary versus behavioral therapy for treatment of stress urinary incontinence (SUI). METHODS: Change in symptom and condition-specific health-related quality-of-life (HRQOL) measures were compared between pessary and behavioral groups 3 months after randomization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial. Four hundred forty-six women with symptoms of SUI were randomized to continence pessary, behavioral therapy (pelvic floor muscle training and continence strategies) or combination therapy. Validated measures utilized included urinary, prolapse, and colorectal scales of the Pelvic Floor Distress Inventory; urinary, prolapse, and colorectal scales of the Pelvic Floor Impact Questionnaire; and Stress and Urge scales of the Questionnaire for Urinary Incontinence Diagnosis. Student t test and analysis of variance were used to compare scores within and between groups. RESULTS: Mean age of participants was 49.8 (SD, 11.9) years; 84% were white, and 10% were African American. One hundred forty-nine were randomized to pessary, and 146 to behavioral therapy. Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after randomization, but there was no statistically significant difference between groups. CONCLUSIONS: There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI. Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI.
Authors: Holly E Richter; Kathryn L Burgio; Linda Brubaker; Ingrid E Nygaard; Wen Ye; Alison Weidner; Catherine S Bradley; Victoria L Handa; Diane Borello-France; Patricia S Goode; Halina Zyczynski; Emily S Lukacz; Joseph Schaffer; Matthew Barber; Susan Meikle; Cathie Spino Journal: Obstet Gynecol Date: 2010-03 Impact factor: 7.661
Authors: Holly E Richter; Kathryn L Burgio; Patricia S Goode; Diane Borello-France; Catherine S Bradley; Linda Brubaker; Victoria L Handa; Paul M Fine; Anthony G Visco; Halina M Zyczynski; John T Wei; Anne M Weber Journal: Clin Trials Date: 2007 Impact factor: 2.486
Authors: Catherine S Bradley; David D Rahn; Ingrid E Nygaard; Matthew D Barber; Charles W Nager; Kimberly S Kenton; Nazema Y Siddiqui; Robert B Abel; Cathie Spino; Holly E Richter Journal: Neurourol Urodyn Date: 2010-06 Impact factor: 2.696
Authors: Matthew D Barber; Linda Brubaker; Ingrid Nygaard; Thomas L Wheeler; Joeseph Schaffer; Zhen Chen; Cathie Spino Journal: Obstet Gynecol Date: 2009-09 Impact factor: 7.661
Authors: Matthew D Barber; Cathie Spino; Nancy K Janz; Linda Brubaker; Ingrid Nygaard; Charles W Nager; Thomas L Wheeler Journal: Am J Obstet Gynecol Date: 2009-05 Impact factor: 8.661
Authors: Hayser Medina Lucena; Kate Williams; Douglas G Tincello; Allyson Lipp; Chris Shaw Journal: Int Urogynecol J Date: 2018-08-13 Impact factor: 2.894