Mirabegron + Behavioral Therapy for Parkinson's Disease
(SQUARE PD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to find better treatments for overactive bladder symptoms in individuals with Parkinson's Disease. It evaluates whether combining two treatments—exercise-based behavioral therapy and the medication mirabegron, which relaxes bladder muscles—works better than each treatment alone. Participants will begin with either the medication or the exercise therapy, and if that proves ineffective, they will try both together. Suitable candidates have Parkinson’s and frequently experience urgent or frequent urination issues without infections. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.
Do I need to stop my current medications to join the trial?
You may need to stop taking a bladder relaxant for one week before joining the trial. If you're on a diuretic, alpha-blocker, dutasteride, or finasteride, your dose should be stable for a certain period before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What is the safety track record for these treatments?
Studies have shown that mirabegron is generally safe for people with Parkinson's disease who have overactive bladder symptoms. One study found that about 50% of patients noticed symptom improvement after six weeks of taking mirabegron. Only two mild side effects were reported, indicating the drug is well-tolerated.
Another source reviewed FDA reports and identified some side effects, such as irregular heartbeat and palpitations, but these were uncommon. Most participants in these studies handled the treatment well.
In contrast, exercise-based behavioral therapy, which includes pelvic muscle exercises and bladder training, usually has even fewer side effects. Some research suggests it is as effective as drug treatments but without the risk of medication side effects.
Both treatments have been tested in people with Parkinson's, providing data on their safety. This information may help prospective trial participants feel more confident about the options.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about combining Mirabegron with exercise-based behavioral therapy for Parkinson's disease because this approach addresses both medication and lifestyle. Mirabegron, a beta-3 adrenergic agonist, targets bladder muscle relaxation, which may help with urinary symptoms common in Parkinson's patients. The unique combination with behavioral therapy offers a holistic approach, potentially enhancing the overall quality of life by tackling both the physical and lifestyle aspects of managing symptoms. This dual strategy might offer a more comprehensive solution compared to standard treatments that typically focus on one aspect alone.
What evidence suggests that this trial's treatments could be effective for overactive bladder symptoms in Parkinson's Disease?
Research has shown that mirabegron effectively treats overactive bladder symptoms in people with Parkinson's disease. Studies have found it improves bladder control and is safe to use. Mirabegron relaxes the bladder muscles, reducing the frequent urge to urinate. In this trial, some participants will receive mirabegron as part of the drug therapy group.
Behavioral therapy, such as pelvic floor exercises and bladder training, also effectively manages these symptoms. It can be as helpful as medication and has fewer side effects. Participants in this trial may receive exercise-based behavioral therapy as part of the behavioral therapy group. Both mirabegron and behavioral therapy offer promising options for improving bladder control in people with Parkinson's.13467Who Is on the Research Team?
Elizabeth Camille Vaughan, MD MS
Principal Investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
Are You a Good Fit for This Trial?
This trial is for people with Parkinson's Disease who have significant symptoms of an overactive bladder, as indicated by a specific symptom score. Participants must be diagnosed by a specialist neurologist and not have severe cognitive impairment, intensive prior pelvic training, major depression, certain urinary conditions or sensitivities to the study drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either drug therapy with mirabegron or exercise-based behavioral therapy
Re-randomization and Combination Treatment
Non-responders to initial treatment are re-randomized to receive combination therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exercise-based behavioral therapy
- Mirabegron
Trial Overview
The study is testing if mirabegron (a drug) or exercise-based behavioral therapy can help with overactive bladder in Parkinson's patients. If one doesn't work alone, they'll try combining them. The trial also looks at what factors affect treatment response.
How Is the Trial Designed?
3
Treatment groups
Active Control
At 6 weeks post-randomization, participants will complete the ICIQ-OAB questionnaire. Participants reporting less than 2 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.
Participants who are randomized to drug therapy will receive mirabegron 25mg at visit 2 (randomization visit).
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Citations
Behavioral therapy for urinary symptoms in Parkinson's ...
Behavioral therapy included pelvic floor muscle exercises, bladder training, fluid and constipation management. Both groups completed bladder diary self- ...
Behavioral therapy to treat urinary incontinence in ...
This study provides Class IV evidence that exercise-based, biofeedback-assisted behavioral intervention can reduce UI frequency in patients >50 years old with ...
Sequential Multiple Assignment Randomized Trial to Treat ...
The purpose of this study is to learn about different treatments for overactive bladder symptoms in Parkinson's Disease.
Behavioral Therapy for Overactive Bladder in Patients with ...
Behavioral therapy was as effective as drug therapy, with fewer side effects. Patients with Parkinson disease often develop symptoms related to ...
Behavioral Compared With Drug Therapy for Overactive ...
Meaning Results of this study suggest that behavioral therapy is an effective treatment option for persons with PD, and fall risk should be ...
Behavioral Therapy to Treat Urinary Incontinence in ...
Behavioral Therapy to Treat Urinary Incontinence in Parkinson's Disease (BETTUR PD) ; ClinicalTrials.gov ID NCT00866710 ; Sponsor Atlanta VA ...
Conservative management for urinary incontinence in ...
This systematic review was conducted based on the data ... Behavioral therapy for urinary symptoms in parkinson's disease: A randomized clinical trial.
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