N/A
N=70
The Urinary Incontinence Treatment Study
Urinary Incontinence · Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT03057834 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Number of Urinary Incontinence Episodes — 4.3; 2.7 number of incontinence episodes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pelvic floor muscle exercise (Behavioral)
- Age
- Older Adult · 70+ yrs
- Sex
- Female
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Urinary Incontinence Episodes |
3.5; 2.4 | — |
| PRIMARY Number of Urinary Incontinence Episodes |
3.5; 2.4 | — |
| PRIMARY Number of Urinary Incontinence Episodes |
3.5; 2.4 | — |
| SECONDARY Power of Contractions |
19.3; 29.3 | — |
| SECONDARY Endurance |
4.4; 4.7 | — |
| SECONDARY Repetition of Contractions |
9.1; 8.8 | — |
| SECONDARY Number of Fast Contractions |
4.3; 4.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03057834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.