Trial · NCT05880862
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
NCT05880862, Early phase 1, Completed, The University of Texas Medical Branch, Galveston
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls. Trials, record NCT05880862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05880862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
- NCT number
- NCT05880862
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Urinary Bladder, Overactive, Urinary Incontinence, Accidental Falls
- Interventions
- Pelvic Floor Muscle Training, Mirabegron, Trospium Chloride
- First posted
- 2023-05-30
- Last updated
- 2026-06-22
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AG081900 | Comparative effectiveness of pelvic floor muscle training, Mirabegron, and Trospium among older women with urgency urinary incontinence and high fall risk: a feasibility randomized clinical study. | FISHER, STEVEN R | UNIVERSITY OF TEXAS MED BR GALVESTON | NATIONAL INSTITUTE ON AGING | 2023 to 2024 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05880862
GET https://conductscience.org/api/trials/v1/NCT05880862/registered