The Urinary Incontinence Treatment Study

Sarcopenia Clinical Trial

— UNITS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057834
• Other study ID #: IRB00038710
• Secondary ID: R03AG056460
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: January 29, 2020

Study information

• Verified date: January 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Sarcopenia
• Urinary Incontinence

Intervention

Behavioral:
• Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of urinary incontinence episodes	Using a voiding diary	Baseline through Week 6