Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women A Randomized Clinical Trial
Objective: To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women.
Design, Setting, And Participants: Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), symptoms of at least 3 months’ duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study
Interventions: The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD.
Main Outcomes and Measures: Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment.
Results: Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, −1.51 to −0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months
Conclusions and Relevance: The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI.
ClinicalTrials.gov identifier: NCT02001714
JAMA Intern Med. doi:10.1001/jamainternmed.2018.3766
Published online September 4, 2018.
Authors: Ananias C. Diokno, MD; Diane K. Newman, DNP; Lisa K. Low, PhD; Tomas L. Griebling, MD, MPH; Michael E. Maddens, MD; Patricia S. Goode, MD; Trivellore E. Raghunathan, PhD; Leslee L. Subak, MD; Carolyn M. Sampselle, PhD; Judith A. Boura, MS; Ann E. Robinson, RN, MSA; Donna McIntyre, BBA; Kathryn L. Burgio, PhD
Author Affiliations: Department of Urology, Beaumont Hospital, Royal Oak, Michigan (Diokno, Robinson); Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia (Newman); Department of Health Behavior and Biological Sciences, University of Michigan School of Nursing, Ann Arbor (Low, Sampselle); Department of Urology, University of Kansas School of Medicine, Kansas City (Griebling); The Landon Center on Aging, University of Kansas School of Medicine, Kansas City (Griebling); Department of Internal Medicine, Beaumont Hospital, Royal Oak, Michigan (Maddens); Department of Medicine, University of Alabama at Birmingham (Goode, Burgio); Birmingham/Atlanta Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Birmingham, Alabama (Goode, Burgio); Institute for Social Research, University of Michigan, Ann Arbor, Michigan (Raghunathan); Department of Obstetrics and Gynecology, Stanford University, Palo Alto, California (Subak); Research Institute, Beaumont Hospital, Royal Oak, Michigan (Boura, McIntyre).
Further Related Content:
Randomized Controlled Trial of Group-Administered Behavioral Treatment in Reducing Urinary Incontinence in Adult Women
Is a Group Learning Behavioral Modification Program Effective and Safe in Reducing Geriatric Urinary Incontinence? A Multi-Center Randomized Controlled Trial