Self-Care to Prevent Birth-Related Urinary Incontinence in Diverse Women



Status:Archived
Conditions:Women's Studies, Urology
Therapuetic Areas:Nephrology / Urology, Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2007
End Date:December 2012

Use our guide to learn which trials are right for you!

PERL 4: Promoting Effective Recovery From Labor


The primary goal of this project is to determine the efficacy of an antenatal Bladder Health
class to prevent UI in a diverse sample of African American, Caucasian, and Hispanic
childbearing women. The determination of efficacy will be made at 12-months post index
birth, a time point that is a traditional benchmark of recovery from childbirth, using UI
incidence/severity as the primary outcome.


This study is significant because UI prevalence is 34% overall among US women, nearly half
of whom consider their incontinence to be moderately to extremely bothersome. UI is 2.0 to
2.6 fold greater in women after pregnancy and childbirth as compared to their never pregnant
counterparts, with the incidence increasing after each child. UI impact increases as women
age extending into middle and later life. The financial cost of UI in the United States
exceeds $19 billion per year . Other costs are identified in the Healthy People 2010 report
22 and include: 1) decreased activity/ fitness, which can be seriously affected because
women who are concerned about accidental leakage markedly curtail physical activity and 2)
increased depression, which has been linked to UI in women. Women are at least twice as
likely as men to have UI; pregnancy and childbirth are major explanatory factors. In
perimenopausal women, prevalence of any UI was 57% and of moderate to severe UI was 25%;
after controlling for age, race/ethnicity, menopausal status and body mass index, parity
persisted as a significant predictor of UI with an OR of 1.62 (CI 1.31, 2.01).

Noninvasive interventions during the period of childbearing are of particular interest for
UI prevention in women. Two self-management practices recommended for the initial treatment
of UI are: Pelvic floor muscle training (PFMT), defined by the International Continence
Society as repetitive selective voluntary contraction and relaxation of specific pelvic
floor muscles, and bladder training (BT), defined as a program of scheduled voiding with
gradually progressive voiding intervals. The Knack Maneuver (a preemptive pelvic floor
muscle contraction to decrease stress UI and/or suppress urge UI) has demonstrated efficacy
in older women diagnosed with UI. In childbearing women, only PFMT has been tested with a
rigorous RCT design. We taught PFMT, the Knack, and BT as a combined strategy to older
women and found a two-fold prevention effect. The proposed project is innovative because it
will be the first to our knowledge to test the preventive capacity of an intervention in
childbearing women that combines PFMT, the Knack, and BT. This project is also innovative
because it will be conducted with a diverse sample of primiparous/multiparous women, using a
3-year follow-up period. Because PFMT is the only self-management strategy that is
currently recommended practice for maternity patients, we will use PFMT adherence in
comparisons between the treatment and control conditions

Recruitment and Informed Consent:

Fliers specifying eligibility criteria and benefits of research participation will be
prominently displayed in the waiting areas and in the women's bathrooms of the respective
clinical sites. Potential participants will be invited to speak with a designated
site-based contact re: what participation in the study would entail. This individual will
answer initial questions, review written material that describes study participation,
conduct verbal screening, and obtain informed consent from eligible individuals. Eligible
participants will be scheduled for a clinic visit at the respective site for a clinic visit
to obtain clinical verification of no objective incontinence (negative standing stress test)
and evidence of ability to contract the pelvic floor correctly (digital measure). Following
determination of eligibility, participants will be randomized into control (routine care) or
treatment (scheduled for Bladder Health class) condition.


We found this trial at
3
sites
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health Systems The University of Michigan is home to one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Jackson, Michigan 49202
?
mi
from
Jackson, MI
Click here to add this to my saved trials
Pontiac, Michigan 48341
?
mi
from
Pontiac, MI
Click here to add this to my saved trials