The Urinary Incontinence Treatment Study



Status:Recruiting
Conditions:Overactive Bladder, Orthopedic, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Orthopedics / Podiatry
Healthy:No
Age Range:70 - Any
Updated:2/7/2019
Start Date:March 1, 2017
End Date:January 2020
Contact:Kimberly Kennedy
Email:kkennedy@wakehealth.edu
Phone:336.713.8567

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Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women

Investigators plan a prospective cohort study with an adaptive design based on physical
function status. The design will involve tracking the number of women recruited with physical
function impairment and those without any functional impairment. Investigators aim to recruit
similar numbers of women in each group. If investigators find unequal numbers, they will
adapt recruit strategies based on a woman's functional status.

Investigators plan a prospective cohort study with an adaptive design based on physical
function status. The design will involve tracking the number of women recruited with physical
function impairment and those without any functional impairment. Investigators aim to recruit
similar numbers of women in each group. If they find unequal numbers, they will adapt recruit
strategies based on a woman's functional status.

Investigators will compare changes in outcome measures within and between groups after 6 and
12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor
strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and
will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI
symptoms on quality of life will be determined using standardized measures described above.
Data analysis will define associations between changes in PERFECT measures and the change in
UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact
on quality of life (PFIQ-7) within and between groups. Objective measurement of
lower-extremity strength will inform the relationship between lower-extremity strength,
pelvic floor strength, and UI symptoms at baseline and the 6-week visit.

Inclusion Criteria:

- Women, age 70 years or older

- Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale
score for stress ≥4, and/or urge score ≥ 6)

- Willing and able to be compliant with pelvic floor muscle exercise intervention
(standard of care) for 12 weeks and to log compliance

- Willing and able to undergo an extensive physical function evaluation

Exclusion Criteria:

- Prior surgical intervention for urinary incontinence within the past 12 months

- Hysterectomy within 12 months

- Diagnosis of:

- Pelvic Organ Prolapse beyond the hymenal ring

- Urogenital Fistula

- Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or
Stroke within past 12 months)

- Incomplete Bladder Emptying/Urinary Retention with PVR >150 ml (measured by bladder
scan)

- Requires assisted device (4 point cane, walker) for ambulation all /most of the time
or wheelchair bound

- Having significant cognitive impairment or dementia

- Unsafe to exercise (severe cardiopulmonary disease)

- Unable/unwilling to provide informed consent

- Determined otherwise ineligible by the principal investigator
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Phone: 336-713-8567
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Winston-Salem, NC
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