Deprescribing Overactive Bladder Medications for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if individuals with Parkinson's disease can safely reduce or stop using medications for overactive bladder. Researchers will gradually lower the dose of these medications, known as antimuscarinics, to assess if symptoms remain manageable without them. The trial explores whether fewer medications could enhance life quality for those with Parkinson's. It suits individuals with Parkinson's who have taken these bladder medications for at least three months and can engage in online and phone activities. As a Phase 4 trial, the treatment has already received FDA approval and proven effective. This research seeks to understand its benefits for more patients, offering a unique opportunity to contribute to broader knowledge while potentially improving personal health outcomes.
Do I need to stop my current medications for the trial?
Yes, you will need to gradually reduce and aim to stop your overactive bladder medication during certain periods of the trial. The trial involves reducing the dose by 25-50% every 1-2 weeks with the goal of completely discontinuing the medication.
What is the safety track record for overactive bladder antimuscarinic deprescribing?
Research has shown that antimuscarinic medications, commonly used to treat overactive bladder (OAB), may pose safety concerns, particularly for individuals with Parkinson's disease. Studies suggest these medications might increase the likelihood of requiring urgent medical care compared to other treatments. Evidence also indicates that these drugs can impair memory and thinking skills, potentially leading to cognitive decline.
This trial focuses on "deprescribing," which involves gradually discontinuing the medication. The goal is to reduce potential risks by slowly lowering the dose. As a Phase 4 trial, it builds on previous research, indicating the treatment has been tested for safety, but further study is needed to understand long-term effects. Prospective participants should discuss these potential risks and benefits with their healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about deprescribing overactive bladder medications for Parkinson's disease because it explores a method to potentially reduce medication burden. Unlike the standard approach where antimuscarinic medications are maintained indefinitely, this method gradually tapers the dosage to find the lowest effective dose or to discontinue entirely. This approach could help minimize side effects while still managing symptoms, offering a personalized treatment strategy that balances efficacy with quality of life.
What evidence suggests that deprescribing overactive bladder medications could be effective for Parkinson's disease?
Research has shown that people with Parkinson's disease often experience bladder problems, known as overactive bladder (OAB). Antimuscarinic medications are commonly used to treat OAB symptoms, but they can cause side effects such as dry mouth and constipation. Studies indicate that these medications can alleviate symptoms like the urgent need to urinate and frequent urination, though issues like nocturia (needing to urinate at night) might still occur. However, limited information exists on the long-term safety of these drugs for people with Parkinson's. In this trial, participants will follow a single-arm AB(AB) sequence to evaluate whether reducing or stopping these medications might help without worsening symptoms.12356
Are You a Good Fit for This Trial?
This trial is for people with Parkinson's disease who are currently taking medication for overactive bladder, specifically antimuscarinic drugs. Participants must be willing to try reducing or stopping this medication under medical supervision.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1 (ON)
Participants continue their overactive bladder antimuscarinic at their maintenance dose
Treatment Period 2 (OFF)
Antimuscarinic dose is gradually tapered by 25-50% every 1-2 weeks until discontinuation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Overactive bladder antimuscarinic deprescribing
Trial Overview
The study tests whether gradually lowering and possibly stopping overactive bladder antimuscarinic medications in people with Parkinson’s can be done safely. Each person alternates between periods of taking their usual dose and periods of reduced or no medication.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will follow a single-arm AB(AB) sequence. During the initial "ON" \[A\] period, participants will continue their overactive bladder antimuscarinic at their maintenance dose for up to 10 weeks. This will be followed by an "OFF" \[B\] period of up to 10 weeks, during which the antimuscarinic will be gradually tapered by approximately 25%-50% every 1-2 weeks until the lowest effective dose or complete discontinuation is reached. A second AB sequence may be repeated, if needed.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corporal Michael J. Crescenz VA Medical Center
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Citations
Comparative Safety of Antimuscarinics versus Mirabegron for ...
Overactive bladder (OAB) is a common nonmotor symptom of Parkinson disease (PD). There is lack of safety data of antimuscarinics vs. mirabegron for OAB ...
Pilot Deprescribing of Antimuscarinic Overactive Bladder ...
The investigators will evaluate the effects of deprescribing overactive bladder (OAB) antimuscarinics in individuals with Parkinson disease (PD) ...
Comparative safety of antimuscarinics versus mirabegron ...
Antimuscarinics were associated with greater acute care event risks vs. mirabegron. Long-term safety of these agents in PD should be evaluated in a prospective ...
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ctv.veeva.com
ctv.veeva.com/study/pilot-deprescribing-of-antimuscarinic-overactive-bladder-medications-in-parkinson-diseasePilot Deprescribing of Antimuscarinic Overactive Bladder ...
This is an unblinded, non-randomized National Institute of Health (NIH) Stage I of Behavioral Intervention Development trial.
Current Grantees and their Projects
This study addresses a critical gap by applying N-of-1 trials to evaluate the necessity of OAB antimuscarinic use in older adults with PD, generating ...
Comparative safety of antimuscarinics versus mirabegron ...
Overactive bladder (OAB) is a common non-motor symptom of Parkinson disease (PD), often treated with antimuscarinics or beta-3 agonists.
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