Mind Over Matter; Healthy Bowels, Healthy Bladder: An Individually Randomized Group Treatment Trial

Braun E J1, Wise M E1, Jansen S1, Myers S2, Sampene E1, Li Z1, Moberg D P1, Rogers R G3, Mahoney J E1, Brown H W1

Research Type

Clinical

Abstract Category

Prevention and Public Health

PRIZE AWARD: Best in Category Prize - Prevention and Public Health
Abstract 469
Best Conservative Management
Scientific Podium Session 25
Friday 31st August 2018
09:30 - 09:45
Hall B
Anal Incontinence Female Incontinence Prospective Study Pelvic Floor
1. University of Wisconsin-Madison, 2. Wisconsin Institute for Healthy Aging, 3. Dell Medical School
Presenter
H

Heidi W Brown

Links

Abstract

Hypothesis / aims of study
Mind Over Matter; Healthy Bowels, Healthy Bladder (MOM) is a four-week, community-based, small-group behaviour intervention led by a trained facilitator. MOM builds skills and self-efficacy to change behaviours to promote continence, and improved both urinary (UI) and faecal incontinence (FI) in pilot-testing. We sought to determine the impact of MOM on UI, FI, and care-seeking for incontinence among older women using a randomized, waitlist control trial.
Study design, materials and methods
In this individually randomized group treatment trial, 16-30 women with UI and/or FI were recruited from each of 6 communities (target sample size 110). Women allocated to the treatment arm completed MOM in their community immediately after baseline assessment, and trained fidelity observers attended intervention sessions to monitor adherence of intervention protocol. The primary outcome was UI symptom improvement as measured by the Patient Global Impression of Improvement (PGI-I) at four months. Secondary outcomes assessed via validated measures were UI and FI symptoms, self-efficacy, and depression. Participants were also asked about behaviour changes and care-seeking for UI and FI. Using intent-to-treat analyses, McNemar’s Chi-square test compared categorical outcomes and t-test compared differences in means for continuous variables between treatment and control groups.
Results
Of 166 women screened, 122 were consented and 121 randomized (62 treatment; 59 control); 116 (95%) completed the 4-month assessment. Trained observers confirmed no major lapses to intervention delivery with fidelity in the treatment groups. There were no significant between-group differences at baseline (Table 1). At 4 months 71% of treated women, vs. 23% of controls, reported improved UI on PGI-I (p<.01); 39% vs. 5% were much or very much improved (p<.01). Regarding FI, 55% of treated women, versus 27% of controls, improved on PGI-I (p<.05), with 35% vs. 10% reporting significant improvement (p<.05). Odds ratios did not change significantly when controlling for community (Table 2). Treated women improved more than controls on all validated instruments of UI and FI severity, quality of life, and self-efficacy (Table 3). In the treatment group, the proportion performing Kegels often or always was 16% at baseline, 93% at 1 month, and 62% at 4 months, while the control group remained steady at 9%, 8%, and 9%, respectively (p<.001). Care-seeking rates were similar between groups at 4 month assessment, with 46% of treated women and 45% of controls planning to talk with a healthcare provider about UI (p=.94) and 28% versus 37% planning to talk with a provider about FI (p=.34).
Interpretation of results
Participation in MOM improved both UI and FI and resulted in sustained behaviour change four months after initiating the intervention, and did not impact rates of care-seeking for UI or FI.
Concluding message
Given these promising effectiveness data, MOM should be disseminated more broadly. Subsequent research should evaluate long-term impact on symptoms as well as effectiveness in other populations.
Figure 1
Figure 2
Disclosures
Funding 1) NIH K12DK100022; 2) Wisconsin Partnership Program New Investigator Program Award Clinical Trial Yes Registration Number www.clinicaltrials.gov; NCT02671747 RCT Yes Subjects Human Ethics Committee Minimal Risk Health Sciences Institutional Review Board at UW-Madison School of Medicine and Public Health Helsinki Yes Informed Consent Yes