- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880862
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
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
The goal of this study is to conduct a randomized pilot multi-arm clinical trial comparing a standard course of physical therapist provided pelvic floor muscle training (PFMT) to pharmacologic therapy for the treatment of urgency urinary incontinence (UUI) or Overactive Bladder (OAB) in older women at high risk of falling.
The central hypotheses for this project are i) a randomized pilot multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling is feasible; and ii) treatment approach can influence both UI and fall related outcomes in this patient population.
The main questions it aims to answer are: 1) Is a multi-arm clinical trial comparing PFMT to drug treatment for UUI or OAB in older women at high risk of falling feasible? and 2) How does treatment approach influence both OAB and fall related outcomes in this patient population?
Women (16 per arm) 60 years and older with UUI or OAB who screen positive for high fall risk will be randomized to one of three standard of care treatment arms and followed for six months. The three treatment arms are i) a 12-week structured behaviorally based pelvic floor muscle training (PFMT) intervention administered by physical therapists in the clinic; ii) a 12-week course of the beta-3 agonist, Mirabegron; and iii) a 12-week course of the antimuscarinic, Trospium Chloride. Researchers will compare study feasibility and OAB symptom related outcomes across the three groups to see if a larger clinical trial is warranted.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Steve Fisher, PT, PhD
- Phone Number: 4097723068
- Email: stfisher@utmb.edu
Study Locations
-
-
Texas
-
Galveston, Texas, United States, 77555
- Recruiting
- University of Texas Medical Branch at Galveston
-
Contact:
- Steve Fisher, PT, PhD
- Phone Number: 409-772-3068
- Email: stfisher@utmb.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 60 year or older.
- Ambulatory (able to walk across a small room with or without an assistive device).
- Urgency UI, OAB, or Mixed UI (both urgency and stress UI) as identified by study physicians.
- Answered "yes" to one of the items on the 3-Key Questions, questionnaire.
- A score of 6 or greater on the International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB) instrument or a physician recommended treatment.
- Able to provide one's own informed consent.
- Has tried basic lifestyle modifications for her bladder condition.
- Has Medicare or private insurance
Exclusion Criteria:
- Male (their causes of urinary incontinence are often different from women)
- Unstable psychiatric conditions (e.g., psychosis, suicidal) based on history and medical records.
- Nursing home resident
- Genitourinary cancer undergoing active treatment with chemotherapy or radiation.
- Neurologic conditions known to contribute to incontinence (Multiple Sclerosis, Parkinson's Disease, Traumatic Brain Injury, Dementia, and Stroke Survivors with limited mobility)
- New OAB treatments planned during the 6-month study duration - includes medications and/or surgery.
- History of surgically implanted sacral nerve stimulator or botulinum toxin bladder injections for UI.
- Taking other antimuscarinic drugs or Digoxin
- Severe uncontrolled hypertension
- Diagnosed Glaucoma
- Myasthenia gravis
- Chronic liver or kidney diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pelvic Floor Muscle Training
A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)
|
A 12-week, 6 visit, outpatient program of physical therapist delivered behavioral and pelvic floor muscle training (PFMT)
|
Active Comparator: Mirabegron
Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.
|
Individually titrated Mirabegron, starting at 25 mg daily and increased to 50 mg daily at 6-weeks, during the 12-week intervention period.
Other Names:
|
Active Comparator: Trospium Chloride
A 12-week course of Trospium -extended release, 60mg once daily.
|
A 12-week course of Trospium XL -extended release, 60mg once daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluability
Time Frame: 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.
|
Assessed at the end of the 12-week intervention period
|
Clinical-Based Adherence
Time Frame: 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.
|
Assessed at the end of the 12-week intervention period
|
Home-Based Adherence
Time Frame: 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.
|
Assessed at the end of the 12-week intervention period
|
Medication Adherence
Time Frame: 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.
|
Assessed at the end of the 12-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Consultation on Incontinence Modular Questionnaire - Overactive Bladder (ICIQ-OAB)
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Falls Efficacy Scale International (FES-I)
Time Frame: 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).
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Number of Participants with Incident falls
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
PROMIS Satisfaction with Participation in Social Roles
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Short Physical Performance Battery (SPPB)
Time Frame: 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).
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Physical activity
Time Frame: 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.
|
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.
|
PROMIS physical functioning 8b
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Absorbent pad use
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative interviews
Time Frame: 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.
|
Baseline; at the end of the 12-week intervention; and at the 6-month follow-up.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steve Fisher, University of Texas Medical Branch at Galveston
Publications and helpful links
General Publications
- Foley AL, Loharuka S, Barrett JA, Mathews R, Williams K, McGrother CW, Roe BH. Association between the Geriatric Giants of urinary incontinence and falls in older people using data from the Leicestershire MRC Incontinence Study. Age Ageing. 2012 Jan;41(1):35-40. doi: 10.1093/ageing/afr125. Epub 2011 Sep 24.
- Chiarelli PE, Mackenzie LA, Osmotherly PG. Urinary incontinence is associated with an increase in falls: a systematic review. Aust J Physiother. 2009;55(2):89-95. doi: 10.1016/s0004-9514(09)70038-8.
- Brown JS, Vittinghoff E, Wyman JF, Stone KL, Nevitt MC, Ensrud KE, Grady D. Urinary incontinence: does it increase risk for falls and fractures? Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 2000 Jul;48(7):721-5. doi: 10.1111/j.1532-5415.2000.tb04744.x.
- Balk E, Adam GP, Kimmel H, Rofeberg V, Saeed I, Jeppson P, Trikalinos T. Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Aug. Report No.: 18-EHC016-EFReport No.: 2018-SR-03. Available from http://www.ncbi.nlm.nih.gov/books/NBK534625/
- Gibson W, Hunter KF, Camicioli R, Booth J, Skelton DA, Dumoulin C, Paul L, Wagg A. The association between lower urinary tract symptoms and falls: Forming a theoretical model for a research agenda. Neurourol Urodyn. 2018 Jan;37(1):501-509. doi: 10.1002/nau.23295. Epub 2017 May 4.
- Fisher SR, Harmouche I, Kilic GS. Prevalence and Predictors of Increased Fall Risk Among Women Presenting to an Outpatient Urogynecology and Pelvic Health Center. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):e7-e10. doi: 10.1097/SPV.0000000000001118.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Bladder, Overactive
- Urinary Incontinence
- Enuresis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Adrenergic beta-3 Receptor Agonists
- Mirabegron
- Trospium chloride
Other Study ID Numbers
- 22-0262
- R21AG081900 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Bladder, Overactive
-
Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
-
Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
-
Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
-
Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
-
Beijing Pins Medical Co., LtdUnknown
-
Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
-
Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey
Clinical Trials on Pelvic Floor Muscle Training
-
Hacettepe UniversityCompletedStress Urinary IncontinenceTurkey
-
Herlev HospitalCompletedUrinary Stress IncontinenceDenmark
-
Trakya UniversityCompletedStress Urinary Incontinence | Pelvic Floor Muscle Weakness
-
Norwegian School of Sport SciencesTerminatedUrinary Incontinence | Stress Urinary IncontinenceNorway
-
Hatice Gulsah KurneRecruitingSexual Dysfunction | Pelvic Floor Muscle Weakness | Postmenopausal SymptomsTurkey
-
YI-JU TSAIWithdrawn
-
Hasan Kalyoncu UniversityNot yet recruiting
-
Hospital de Clinicas de Porto AlegreWithdrawn
-
Dokuz Eylul UniversityIzmir Katip Celebi UniversityCompletedMultiple Sclerosis | Urinary IncontinenceTurkey
-
Centre Hospitalier Universitaire de la RéunionInstitut National de la Santé Et de la Recherche Médicale, France; CIC-EC RéunionCompletedUrinary Incontinence | Anal Incontinence | Genital ProlapseFrance