Study Results
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View full resultsBasic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2017-03-01
2020-01-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Functionally impaired
Women with urinary incontinence and short physical performance battery score of \<9
Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen
Functionally normal
Women with urinary incontinence and short physical performance battery score of \> 10
Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen
Interventions
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Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
FEMALE
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Candace Parker-Autry, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Countries
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References
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Parker-Autry C, Neiberg R, Leng XI, Matthews CA, Dumoulin C, Kuchel G, Kritchevsky SB. Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence. Obstet Gynecol. 2022 Aug 1;140(2):243-251. doi: 10.1097/AOG.0000000000004852. Epub 2022 Jul 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00038710
Identifier Type: -
Identifier Source: org_study_id