drugset / Trial / NCT03149809

Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

NCT03149809

Phase 3 Completed 77 enrolled VA Office of Research and Development
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2018-03-01
Primary completion
2023-09-08
Completion
2023-09-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Solifenacin Small molecule 5 mg
Comparator Solifenacin Small molecule 10 mg