Mon, Feb 13, 2017 at noon:
a PSC Research Project [ARCHIVE DISPLAY]
Investigator: Janis Miriam Miller
More than one in three US women suffers from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI) 1; 2. UI severity increases with age and the financial cost exceeds $19 billion per year 3. Based on level A evidence, the Adult Conservative Management Committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI; and that bladder training (BT) may be preferred to drug therapy 4. Conservative strategies are low risk and differ from other forms of UI management in that they do not prejudice future treatments. We reasoned that such self-management practices should also prevent UI and conducted a RCT to test a prevention behavior modification program. A group session presented an array of conservative self-management practices? PFMT, BT and the Knack Maneuver, which is a preemptive contraction to decrease stress UI and/or suppress urge UI 5. At 12-months post-intervention we found a two-fold UI prevention effect 6. Moreover, we found high and sustained adherence: 82% at 3 months post intervention and 68% at 12 months 7. At four years follow-up, sustained adherence of 70% was predicted by early self-efficacy 8. This intervention is novel because it enables women to adopt and sustain efficacious bladder health practices for incontinence prevention, whereas to date conservative management approaches have focused on treatment. Based on what we now know, these practices should be part of standard well woman care, but it is not realistic to expect busy clinicians to provide this information within the confines of a brief encounter. We have developed a 15-minute DVD that is a condensed version of the group session; it is culturally sensitive and has yielded comparable levels of knowledge and self-efficacy. We aim to compare the efficacy and cost-effectiveness of the group session to the DVD version by randomizing 400 women aged 55 years and older to a two-armed RCT with follow-up points at 3-months, 12-months, and 24-months post-intervention. Controlling for age and BMI, we will test the hypotheses:
HO1: There will be no difference in UI incidence demonstrated between groups (PRIMARY AIM)
HO2: There will be no difference in post-intervention self-management knowledge between groups
HO3: There will be no difference in post-intervention self-efficacy to adopt strategies between groups
We will conduct an economic analysis comparing the two-hour session with the DVD version. Describing the costs and analyzing the willingness to pay and employment data will be the primary focus of this study in order to create the foundation for a future cost-effectiveness analysis, should trial hypotheses be confirmed. At 36-months post-intervention, we will conduct interviews to learn which intervention elements contributed to sustainability of adherence. Our long-range objective is to provide a UI prevention intervention suitable for wide-spread translation at the point of standard well woman care.
|Funding:||National Institute of Nursing Research (1 R01 NR 012011 01)|
Funding Period: 09/28/2010 to 06/30/2016
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