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The Urinary Incontinence Treatment Study (UNITS)

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ClinicalTrials.gov Identifier: NCT03057834
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Sarcopenia Behavioral: Pelvic floor muscle exercise Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be determined based on the score on the SPPB.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Functionally impaired
Women with urinary incontinence and short physical performance battery score of <9
Behavioral: Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen

Placebo Comparator: Functionally normal
Women with urinary incontinence and short physical performance battery score of > 10
Behavioral: Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen




Primary Outcome Measures :
  1. Change in urinary incontinence episodes [ Time Frame: Baseline, 6 weeks ]
    Using a voiding diary



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be born a woman due to the nature of the intervention investigators are studying.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057834


Contacts
Contact: Kimberly Kennedy 336.713.8567 kkennedy@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kimberly Kennedy    336-713-8567    kkennedy@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
Principal Investigator: Candace Parker-Autry, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03057834     History of Changes
Other Study ID Numbers: IRB00038710
R03AG056460 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Sarcopenia
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical