The Urinary Incontinence Treatment Study (UNITS)

Wake Forest University (WFU)

Status: Completed

Conditions: Sarcopenia; Urinary Incontinence

Treatments: Behavioral: Pelvic floor muscle exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03057834

R03AG056460 (U.S. NIH Grant/Contract)

IRB00038710

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: Female

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups, including a placebo group

Functionally impaired

Active Comparator group

Description:

Women with urinary incontinence and short physical performance battery score of \<9

Treatment:

Behavioral: Pelvic floor muscle exercise

Functionally normal

Placebo Comparator group

Description:

Women with urinary incontinence and short physical performance battery score of \> 10

Treatment:

Behavioral: Pelvic floor muscle exercise