At a glance
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Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
In Brief
A Phase 3 clinical trial evaluating solifenacin and Pelvic floor muscle exercise-based behavioral therapy for Overactive Bladder and Parkinson Disease. Completed, enrolled 77 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
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