Trial · NCT05880862
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluability | Assessed at the end of the 12-week intervention period | Number of participants completing the baseline and the post-intervention assessments divided by number enrolled. |
| Primary | Clinical-Based Adherence | Assessed at the end of the 12-week intervention period | Pelvic floor muscle training arm: clinic-based adherence over the 12-week intervention will be calculated by dividing the number of sessions attended by the number of scheduled sessions. |
| Primary | Home-Based Adherence | Assessed at the end of the 12-week intervention period | Home-based adherence will be percentage of adherence to the prescribed home program. Patients complete a home exercise diary each time they perform prescribed exercises. The diaries are taken to every clinic appointment and reviewed by the provider. |
| Primary | Medication Adherence | Assessed at the end of the 12-week intervention period | Medication arms adherence will be calculated as pill counts, i.e., number of pills dispensed minus the number of pills returned. |
| Secondary | International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | The ICIQ-OAB is a patient reported outcome that captures self-perceived degree of urinary frequency, urinary urgency (rushing to the bathroom), and urge incontinence (leakage) as well as symptoms related to nocturia (nighttime urination). The overall score is 0-16 with greater values indicating increased symptom severity. |
| Secondary | International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | The ICIQ-LUTSqol measures the influence of urinary incontinence problems on the quality of life, and changes in interpersonal relations in everyday life. The overall score of ICIQ-LUTSqol is 19-76 score with greater values indicating increased impact on quality of life. |
| Secondary | Falls Efficacy Scale International (FES-I) | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | The Falls Efficacy Scale International (FES-I) is a patient reported outcome that measures level of concern about falling during daily activities inside and outside the home whether or not she actually does the activity. FES-I score ranges from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). |
| Secondary | Number of Participants with Incident falls | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | An event which results in a person coming to rest inadvertently on the ground or floor or other lower level. |
| Secondary | PROMIS Satisfaction with Participation in Social Roles | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | PROMIS self-reported questionnaire that measures the general satisfaction with performing one's usual social roles and activities. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. A higher score equals higher physical functioning. |
| Secondary | Short Physical Performance Battery (SPPB) | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | A battery of 3 physical performance tests: 1) the ability to stand with the feet together in side-by-side, semi-tandem, and tandem positions; 2) time to walk 3 meters; and 3) time to rise from a chair 5 times. A rank ordinal score is given for each test, then all 3 are summed. SPPB total scores range from 0 (worst performance) to 12 (best performance). |
| Secondary | Physical activity | The accelerometer will be worn for 1 week after randomization; for 1 week at the end of the 12-week intervention; and for 1 week at the 6-month follow-up. | Physical activity monitoring via accelerometry will be used to assess sedentary and physical activity behaviors by calculating total number of steps taken per complete 24 hour day (i.e., midnight-to-midnight) during each monitoring period. |
| Secondary | PROMIS physical functioning 8b | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | PROMIS physical function questionnaire assesses self-reported capability rather than actual performance. This includes functioning of upper \& lower extremities, mobility, as well as instrumental activities of daily living, such as running errands. For the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. A higher score equals higher physical functioning. |
| Secondary | Absorbent pad use | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | Self-reported daily number of absorbent pad used in the previous week. Higher numbers of self reported daily pad use is considered worse than low numbers of daily pad use. |
| Other | Qualitative interviews | Baseline; at the end of the 12-week intervention; and at the 6-month follow-up. | Semi-structured interview information will be combined with quantitative trial results to: Explore participants lived experiences with these conditions; perceived benefits and harms of the interventions; and examine factors associated with treatment benefits and harms. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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