The Urinary Incontinence Treatment Study (UNITS)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Sarcopenia
• Intervention / Treatment: Behavioral: Pelvic floor muscle exercise

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
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Urinary Incontinence Episodes	Using a three-day voiding diary	Baseline
Number of Urinary Incontinence Episodes	Using a three-day voiding diary	week 6
Number of Urinary Incontinence Episodes	Using a three-day voiding diary	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power of Contractions	measurement of strength using perineometer	week 12
Endurance	measure of how long they can hold contraction	week 12
Repetition of Contractions	how many repetitions can they sustain	week 12
Number of Fast Contractions	number of fast contractions that can be repeated	week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Organ Prolapse	measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system	baseline, week 12
Short Physical Performance Battery (expSPPB)--Gait Speed	expSPPB scores range from zero to 12 possible points. SPPB score of 0 indicates the lowest physical performance, and a score of 12 indicates the highest performance	week 12
400 Meter Walk	measurement of exercise tolerance	week 12
Isokinetic Dynamometer	maximal isokinetic knee extensor strength in the right leg will be measured at speeds of 60 degrees/sec. The left leg will be used if there is a reason not to measure the right leg.	week 12
Postural Sway	Center-of-Pressure (COP) trajectory data will be collected using an Advanced Mechanical Incorporated (AMTI) AccuSway biomechanics force platform. Participants will be barefoot in an upright stance with arms raised comfortably at their sides, feet abducted, and heels separated. Four posturographic parameters (maximum antero-posterior and medio-lateral displacement, average sway velocity, and 95% confidence ellipse) and two statistical mechanics measures (stabilogram diffusion analysis and detrended fluctuation analysis) will be calculated to quantify postural sway according to our previously published methods.	week 12
Grip Strength	measure of weakness	week 12
Gait Speed	Determined based on 4-meter walk at usual speed	week 12
Strength, Assistance in Walking, Rise From a Chair, Climb Stairs, and Falls (SARC-F) Questionnaire	The SARC-F questionnaire is validated to identify adults with sarcopenia and who are at risk for adverse outcomes and may benefit from a physical function intervention. The scores range from 0 to 10, with 0 to 2 points for each component. A score equal to or greater than 4 is predictive of sarcopenia and poor outcome.	week 12
Appendicular Lean Muscle Mass/Height	calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit	week 12
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire	a brief valid measure that assesses weekly frequency and duration of various physical activities common to older adults to evaluate the efficacy of behavioral interventions to increase levels of physical activity. Caloric expenditure (MET hours/week) will be reported.[8] 'Low activity' will be defined as <6.2 MET-hours/week of activity. Women with MET hr/week between 6.3 and 11.4 will be classified as low-moderate activity. Since only 23% of incontinent women had >11.4 MET hours/week of physical activity, this level will be defined as high activity.	week 12
Barriers to Physical Activity Questionnaire	Questions regarding attitudes towards physical activity considering UI symptoms and perceived barriers will be assessed. 21-item measure assessing the following barriers to physical activity: 1) lack of time, 2) social influence, 3) lack of energy, 4) lack of willpower, 5) fear of injury, 6) lack of skill, and 7) lack of resources (eg, recreational facilities, exercise equipment). Each domain contains 3 items, with a total score range of 0 to 63 with a higher score indicating a higher amount of perceived barriers.	week 12
Mobility Assessment Tool-Short Form (MAT-SF) Score	This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.	week 12
Abdominal Circumference	measure of abdominal circumference will be obtained to determine obesity severity	week 12
Patient Global Impression of Improvement (PGI)	The PGI is a single-item, 7-point scale used to assess a patient's overall perception of their condition's change after treatment. Originating from the Clinical Global Impression-Improvement (CGI-I) scale used by clinicians, the PGI-I allows patients to rate their progress from "Very Much Improved" to "Very Much Worse," providing a simple, validated, and patient-centered outcome measure for various medical and psychiatric conditions. Scores range from 1 (Very Much Improved) to 7 (Very Much Worse).	week 12
Patient Satisfaction Question	Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)	week 12
Estimated Perception of Improvement Question	Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).	week 12
Montreal Cognitive Assessment (MoCA)	MoCA score ranges from 0 to 30 and is used as a screening tool for mild cognitive impairment. A score of 26 or over is considered to be normal.	week 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Candace Parker-Autry, MD, Wake Forest University Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): January 29, 2020
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: February 17, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Sarcopenia
• Other Study ID Numbers: IRB00038710; R03AG056460 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No