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Drug Therapy for Parkinson's Disease (BOSS PD Trial)

Phase 3
Waitlist Available
Led By Elizabeth Camille Vaughan, MD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in qol score at 12 weeks within and between groups
Awards & highlights

BOSS PD Trial Summary

This trial will compare the effectiveness of pelvic floor muscle exercises versus drugs in treating urinary symptoms in Parkinson's Disease, which can lead to increased risk of falls, stress for caregivers, and difficulty with medications.

Eligible Conditions
  • Parkinson's Disease
  • Overactive Bladder

BOSS PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
A specialized doctor who knows a lot about movement disorders has diagnosed you with Parkinson's disease.

BOSS PD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in symptom score at 12 weeks within and between groups
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in symptom score at 12 weeks within and between groups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ICIQ-OAB questionnaire
Secondary outcome measures
Bladder diary
ICIQ-OAB QOL

BOSS PD Trial Design

2Treatment groups
Active Control
Group I: Drug TherapyActive Control1 Intervention
Daily solifenacin drug therapy
Group II: Behavioral therapyActive Control1 Intervention
Pelvic floor muscle exercise-based behavioral therapy

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,608 Previous Clinical Trials
3,306,166 Total Patients Enrolled
Elizabeth Camille Vaughan, MD MSPrincipal InvestigatorAtlanta VA Medical and Rehab Center, Decatur, GA
2 Previous Clinical Trials
359 Total Patients Enrolled

Media Library

Pelvic floor muscle exercise-based behavioral therapy Clinical Trial Eligibility Overview. Trial Name: NCT03149809 — Phase 3
Parkinson's Disease Research Study Groups: Drug Therapy, Behavioral therapy
Parkinson's Disease Clinical Trial 2023: Pelvic floor muscle exercise-based behavioral therapy Highlights & Side Effects. Trial Name: NCT03149809 — Phase 3
Pelvic floor muscle exercise-based behavioral therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03149809 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the FDA's thoughts on Behavioral therapy?

"Behavioral therapy has been shown to be effective in multiple trials and has received a score of 3 for safety."

Answered by AI

How many individuals are allowed to enroll in this experiment?

"That is correct. The clinicaltrials.gov website provides evidence that this study, which was originally posted on March 1st 2018, has open recruitment at present. They need a total of 90 individuals across 2 locations."

Answered by AI

Does literature exist on the efficacy of Behavioral therapy?

"The first behavioral therapy clinical trial was conducted in 2012 at Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences. So far, there have been 90 completed trials with 5 more ongoing studies. The majority of these Decatur, Georgia."

Answered by AI

Are we still looking for participants for this research project?

"That is accurate, the trial detailed on clinicaltrials.gov is currently open for recruitment. The first posting was March 1st, 2018 with the most recent update on January 7th, 2022. They are hoping to find 90 individuals total from 2 locations."

Answered by AI

What types of mental health disorders can be effectively managed with behavioral therapy?

"While commonly used to treat benign prostatic hyperplasia (bph), behavioral therapy can also help patients suffering from overactive bladder syndrome (oabs), tamsulosin, and moderate to severe symptoms."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
2018. "Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03149809.
~11 spots leftby Apr 2025
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