Trial Outcomes & Findings for The Urinary Incontinence Treatment Study (NCT NCT03057834)

Results Overview

Using a three-day voiding diary

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

Baseline

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	33	37
Overall Study Week 6	28	30
Overall Study Week 12	25	29
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	25	29

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	25	29

Baseline Characteristics

The Urinary Incontinence Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Functionally Impaired n=33 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=37 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Total n=70 Participants Total of all reporting groups
Age, Continuous	77.9 years STANDARD_DEVIATION 6.4 • n=5 Participants	76 years STANDARD_DEVIATION 4.1 • n=20 Participants	76.9 years STANDARD_DEVIATION 5.4 • n=40 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	37 Participants n=20 Participants	70 Participants n=40 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=20 Participants	11 Participants n=40 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	32 Participants n=20 Participants	59 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	33 participants n=5 Participants	37 participants n=20 Participants	70 participants n=40 Participants
Body Mass Index (BMI)	33.6 Weight (kg) / Height (m)^2 STANDARD_DEVIATION 14.5 • n=5 Participants	27.5 Weight (kg) / Height (m)^2 STANDARD_DEVIATION 5.8 • n=20 Participants	30.53 Weight (kg) / Height (m)^2 STANDARD_DEVIATION 3.05 • n=40 Participants

PRIMARY outcome

Timeframe: Baseline

Using a three-day voiding diary

Outcome measures

Outcome measures
Measure	Functionally Impaired n=33 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=37 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Number of Urinary Incontinence Episodes	4.3 number of incontinence episodes Standard Deviation 0.6	2.7 number of incontinence episodes Standard Deviation 0.6

PRIMARY outcome

Timeframe: week 6

Using a three-day voiding diary

Outcome measures

Outcome measures
Measure	Functionally Impaired n=28 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=30 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Number of Urinary Incontinence Episodes	3.4 number of incontinence episodes Standard Deviation 0.6	2.3 number of incontinence episodes Standard Deviation 0.6

PRIMARY outcome

Timeframe: week 12

Using a three-day voiding diary

Outcome measures

Outcome measures
Measure	Functionally Impaired n=25 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=29 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Number of Urinary Incontinence Episodes	3.5 number of incontinence episodes Standard Deviation 0.6	2.4 number of incontinence episodes Standard Deviation 0.6

SECONDARY outcome

Timeframe: week 12

measurement of strength using perineometer

Outcome measures

Outcome measures
Measure	Functionally Impaired n=25 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=29 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Power of Contractions	19.3 cmH2O Standard Deviation 13.3	29.3 cmH2O Standard Deviation 16

SECONDARY outcome

Timeframe: week 12

measure of how long they can hold contraction

Outcome measures

Outcome measures
Measure	Functionally Impaired n=25 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=29 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Endurance	4.4 time in seconds Standard Deviation 2.0	4.7 time in seconds Standard Deviation 1.9

SECONDARY outcome

Timeframe: week 12

how many repetitions can they sustain

Outcome measures

Outcome measures
Measure	Functionally Impaired n=25 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=29 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Repetition of Contractions	9.1 number of repetitions Standard Deviation 1.9	8.8 number of repetitions Standard Deviation 1.9

SECONDARY outcome

Timeframe: week 12

number of fast contractions that can be repeated

Outcome measures

Outcome measures
Measure	Functionally Impaired n=25 Participants Women with urinary incontinence and short physical performance battery score of \<9 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen	Functionally Normal n=29 Participants Women with urinary incontinence and short physical performance battery score of \> 10 Pelvic floor muscle exercise: Standardized pelvic floor muscle exercise regimen
Number of Fast Contractions	4.3 number of fast contractions Standard Deviation 1.7	4.7 number of fast contractions Standard Deviation 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, week 12

measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

measurement of exercise tolerance

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

measure of weakness

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

Determined based on 4-meter walk at usual speed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

measure of abdominal circumference will be obtained to determine obesity severity

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 12

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.

Outcome measures

Outcome data not reported

Adverse Events

Functionally Impaired

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Functionally Normal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Candace Parker-Autry, MD

Wake Forest University School of Medicine

Phone: 336-716-3779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place