Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

(BOSS PD Trial)

Recruiting at3 trial locations

Overseen by Elizabeth Camille Vaughan, MD MS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The impact of urinary symptoms in Parkinson disease (PD) extends beyond worsened well-being. Urinary symptoms common in PD, especially incontinence and nocturia, are major risk factors for falls likely due to the combination of urinary urgency and impaired mobility (and falls are a leading cause of mortality in PD), for spouse/caregiver stress due to decreased mutuality in the relationship, and for institutionalization, largely due to increased disability. Additionally, most medications currently recommended for urinary symptoms in PD are anticholinergic and have the potential to worsen the progressive cognitive and autonomic burdens of the disease. Veterans with PD are also more likely to rely solely on VA for their health care than Veterans without PD. Thus, optimizing the care of urinary symptoms for Veterans with PD becomes imperative, particularly for VA. Using a non-inferiority design, this proposal seeks to demonstrate the comparative effectiveness of pelvic floor muscle exercise-based behavioral therapy versus drug therapy to treat urinary symptoms in PD.

Research Team

Elizabeth Camille Vaughan, MD MS

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Eligibility Criteria

Inclusion Criteria

A specialized doctor who knows a lot about movement disorders has diagnosed you with Parkinson's disease.

An ICIQ-OAB Symptom Score of 7, which indicates clinically significant symptoms of OAB, defined as presence of urinary urgency with or without urgency incontinence usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology

Exclusion Criteria

You have participated in intense training for your pelvic floor muscles before.

You have a significant level of depression, as assessed by a questionnaire, that may affect your motivation to fully participate in the study.

Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by site principal investigator

Treatment Details

Interventions

• Pelvic floor muscle exercise-based behavioral therapy (Behavioural Intervention)
• Solifenacin (Antimuscarinic Agent)

Participant Groups

Group I: Drug Therapy Active Control 1 Intervention

Daily solifenacin drug therapy

Group II: Behavioral therapy Active Control 1 Intervention

Pelvic floor muscle exercise-based behavioral therapy

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine