Deprescribing Overactive Bladder Medications for Parkinson's Disease

AW
TP
Overseen ByThanh Phuong Pham Nguyen, PharmD, MBA, MSCE
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Corporal Michael J. Crescenz VA Medical Center
Must be taking: OAB antimuscarinics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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

Are able to receive telephone calls and Zoom calls/telehealth meeting
Are able to provide informed consent
Life expectancy of at least six months
See 4 more

Exclusion Criteria

Have prior history of hypersensitivity or intolerance to mirabegron or vibegron
Have any other condition that, in Principal Investigator and Co-PI's opinion, makes the individual unsuitable for study participation
I have severe kidney problems or need dialysis.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1 (ON)

Participants continue their overactive bladder antimuscarinic at their maintenance dose

10 weeks
Regular monitoring visits

Treatment Period 2 (OFF)

Antimuscarinic dose is gradually tapered by 25-50% every 1-2 weeks until discontinuation

10 weeks
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: AB(AB) armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corporal Michael J. Crescenz VA Medical Center

Lead Sponsor

Trials
31
Recruited
9,900+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

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 ...

Pilot 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.