A Phase 4 interventional study of mirabegron and Exercise-based behavioral therapy in Overactive Bladder and Parkinson Disease, sponsored by VA Office of Research and Development. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment
The purpose of this study is to learn about different treatments for overactive bladder symptoms in Parkinson's Disease. The investigators want to find out if people who do not respond to one treatment (either behavioral or drug treatment) will respond to combined treatment. The investigators also want to find out what factors influence whether someone responds to the treatments.
While Parkinson's Disease (PD) is often characterized by the motor symptoms of the disease (tremor, bradykinesia, rigidity), non-motor symptoms such as urinary symptoms correlate more closely with impaired well-being as the disease progresses. The urinary symptoms of overactive bladder (OAB), including urgency, frequency, and nocturia, with or without urinary incontinence, are the most common urinary symptoms of PD. Because OAB symptoms, such as incontinence and nocturia, are associated with falls (a cause of increased mortality in PD), spouse/caregiver stress, and, ultimately institutionalization, it is critical that the investigators optimize the care of urinary symptoms for Veterans with PD. In the non-PD population, pelvic floor muscle contractions diminish bladder muscle contraction and recent evidence demonstrates that behavioral training with pelvic floor muscle exercises improves the cortical integration of bladder afferent signals. Because of its effectiveness compared to drugs, pelvic floor muscle exercise-based behavioral therapy is recommended first-line in men and women without PD who have OAB. Pelvic floor muscle exercise-based behavioral therapy for urinary symptoms requires individuals to learn a motor skill and implement an adaptive behavioral strategy incorporating pelvic floor muscle contraction to delay the need to void when urgency strikes. The PI's research group demonstrated the feasibility and preliminary efficacy of pelvic floor muscle exercise-based behavioral therapy to treat urgency incontinence in adults with PD. However, the most recent clinical guidelines for the treatment of urinary symptoms in PD recommend treatment with anticholinergic drugs and mention the potential option for noradrenergic bladder relaxants. While some anticholinergic drugs are effective in reducing symptoms of OAB, it is important to note that there is a glaring lack of an empirical evidence base to promote these drugs in the setting of PD given that they add to the anticholinergic burden of antiparkinsonian therapy and may worsen the cognitive and autonomic burdens of the illness. Noradrenergic bladder relaxants may have a more favorable side effect profile; however, the evidence for efficacy in PD is minimal. Therefore, randomized controlled trials (RCTs) are needed to optimize treatment paradigms for urinary symptoms in PD. The investigators' preliminary studies suggest adults with PD and mild cognitive dysfunction can successfully implement behavioral therapy for urinary symptoms. However, in the investigators' most recent VA-funded, multisite trial, 50% of participants reported a clinically significant reduction in urinary symptoms after treatment with either behavioral or drug treatment. Additional research using a Sequential Multiple Assignment Randomized Trial (SMART) design offers an efficient strategy to understand both intervention and patient factors that will inform an individualized treatment plan. With a SMART design, Aim 1 will determine if non-responders to behavioral or drug treatment (expected to be 50% of population) demonstrate a clinically significant response to combination behavior and drug treatment compared to a single treatment approach. In Aim 2, the investigators will determine patient factors that influence optimized treatment of urinary symptoms in Veterans with PD.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 146 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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The criteria were revised on the registry on Oct 27, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who are randomized to drug therapy will receive mirabegron 25mg at visit 2 (randomization visit).
Drug: mirabegron
Participants who are randomized to exercise-based behavioral therapy will receive a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.
Behavioral: Exercise-based behavioral therapy
At 6 weeks post-randomization, participants will complete the ICIQ-OAB questionnaire. Participants reporting less than 3 points reduction will be re-randomized to either continue their initial treatment assignment or receive combination therapy by adding the alternate treatment strategy, thus participants initially treated with mirabegron will add behavioral therapy and participants initially treated with behavioral therapy will add mirabegron.
Drug: mirabegron · Behavioral: Exercise-based behavioral therapy
Mirabegron is a beta-3-agonist, which acts upon the noradrenergic system and avoids the cognitive and gastrointestinal side effects of anticholinergic bladder relaxants.
Also known as: Myrbetriq
The exercise-based behavioral therapy is a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.
ICIQ-OAB
The primary outcome measure at 12 weeks will be urinary symptom severity as measured by the International Consultation on Incontinence Questionnaire-Overactive Bladder module (ICIQ-OAB). Scores range from 0 to 16 with higher scores indicating worse symptom frequency. The symptom score will be collected at 3 time points during the study: baseline, 6-weeks, and 12-weeks.
Time frame: baseline, 6-weeks, and 12-weeks
Plan to share: Yes — Final data sets underlying publications resulting from the proposed research will be shared outside VA through a de-identified, anonymized Dataset under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Mirabegron
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