An interventional study of Pelvic floor muscle exercise in Urinary Incontinence and Sarcopenia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to female participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-10.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 70 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women with urinary incontinence and short physical performance battery score of \<9
Behavioral: Pelvic floor muscle exercise
Women with urinary incontinence and short physical performance battery score of \> 10
Behavioral: Pelvic floor muscle exercise
Standardized pelvic floor muscle exercise regimen
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Time frame: Baseline
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Time frame: week 6
Number of Urinary Incontinence Episodes
Using a three-day voiding diary
Time frame: week 12
Power of Contractions
measurement of strength using perineometer
Time frame: week 12
Endurance
measure of how long they can hold contraction
Time frame: week 12
Repetition of Contractions
how many repetitions can they sustain
Time frame: week 12
Number of Fast Contractions
number of fast contractions that can be repeated
Time frame: week 12
Pelvic Organ Prolapse
measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system
Time frame: 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
Time frame: week 12
400 Meter Walk
measurement of exercise tolerance
Time frame: 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.
Time frame: 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.
Time frame: week 12
Grip Strength
measure of weakness
Time frame: week 12
Gait Speed
Determined based on 4-meter walk at usual speed
Time frame: 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.
Time frame: week 12
Appendicular Lean Muscle Mass/Height
calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 12
Abdominal Circumference
measure of abdominal circumference will be obtained to determine obesity severity
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: week 12
| Milestone | Functionally Impaired | Functionally Normal |
|---|---|---|
| Started | 33 | 37 |
| Week 6 | 28 | 30 |
| Week 12 | 25 | 29 |
| Completed | 8 | 8 |
| Not completed | 25 | 29 |
| Withdrew: Withdrawal by subject | 25 | 29 |
Using a three-day voiding diary
| number of incontinence episodes | Functionally Impaired | Functionally Normal |
|---|---|---|
| Number of Urinary Incontinence Episodes | 4.3 ± 0.6 | 2.7 ± 0.6 |
Using a three-day voiding diary
| number of incontinence episodes | Functionally Impaired | Functionally Normal |
|---|---|---|
| Number of Urinary Incontinence Episodes | 3.4 ± 0.6 | 2.3 ± 0.6 |
Using a three-day voiding diary
| number of incontinence episodes | Functionally Impaired | Functionally Normal |
|---|---|---|
| Number of Urinary Incontinence Episodes | 3.5 ± 0.6 | 2.4 ± 0.6 |
measurement of strength using perineometer
| cmH2O | Functionally Impaired | Functionally Normal |
|---|---|---|
| Power of Contractions | 19.3 ± 13.3 | 29.3 ± 16 |
measure of how long they can hold contraction
| time in seconds | Functionally Impaired | Functionally Normal |
|---|---|---|
| Endurance | 4.4 ± 2.0 | 4.7 ± 1.9 |
how many repetitions can they sustain
| number of repetitions | Functionally Impaired | Functionally Normal |
|---|---|---|
| Repetition of Contractions | 9.1 ± 1.9 | 8.8 ± 1.9 |
number of fast contractions that can be repeated
| number of fast contractions | Functionally Impaired | Functionally Normal |
|---|---|---|
| Number of Fast Contractions | 4.3 ± 1.7 | 4.7 ± 1.5 |
measured using the standardized Pelvic Organ Prolapse Quantification (POP-Q) system
Results for this outcome have not been posted.
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
Results for this outcome have not been posted.
measurement of exercise tolerance
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
measure of weakness
Results for this outcome have not been posted.
Determined based on 4-meter walk at usual speed
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
calculated based upon a whole-body DEXA scan performed in the Geriatric Research Unit
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
This tool shows self-reported mobility. The score range is 30-80 and a higher score denotes better self-reported mobility.
Results for this outcome have not been posted.
measure of abdominal circumference will be obtained to determine obesity severity
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Participants are asked how satisfied they are with their progress in this program. Score ranges from 1 (Completely) to 3 (Not at all)
Results for this outcome have not been posted.
Participants estimate how much better they are on a scale from 0% (no better) to 100% (completely better).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Collected from baseline through week 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Functionally Impaired | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Functionally Normal | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | Functionally Impaired | Functionally Normal | Total |
|---|---|---|---|
| Mean | 77.9 ± 6.4 | 76 ± 4.1 | 76.9 ± 5.4 |
| Sex: Female, Male(Participants) | Functionally Impaired | Functionally Normal | Total |
|---|---|---|---|
| Female | 33 | 37 | 70 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Functionally Impaired | Functionally Normal | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 5 | 11 |
| White | 27 | 32 | 59 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Functionally Impaired | Functionally Normal | Total |
|---|---|---|---|
| United States | 33 | 37 | 70 |
| Body Mass Index (BMI)(Weight (kg) / Height (m)^2) | Functionally Impaired | Functionally Normal | Total |
|---|---|---|---|
| Mean | 33.6 ± 14.5 | 27.5 ± 5.8 | 30.53 ± 3.05 |
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Wake Forest University Health Sciences