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Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

NCT03149809 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-09-24

Study results available
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Summary

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.

Conditions

Interventions

DRUG

solifenacin

Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors

BEHAVIORAL

Pelvic floor muscle exercise-based behavioral therapy

Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Elizabeth Camille Vaughan, MD MS · Atlanta VA Medical and Rehab Center, Decatur, GA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2023-09-08
Completion
2023-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149809 on ClinicalTrials.gov