Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

N2293-I

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.

2018-03-01

2023-09-08

2023-09-08

Completed

Early phase I

77

Inclusion Criteria: * Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders * 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: * Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of \< 18, which is the recommended diagnostic cutpoint for dementia in PD. * Previous intensive pelvic floor muscle exercise training * Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score 10 which could affect motivation to fully engage in the intervention * Use of an indwelling urinary catheter * Post-void residual (PVR) urine measurement by bladder ultrasound of 150 mL * Severe uterine prolapse past the vaginal introitus * Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of \>9.0% within the last 3 months. Participants with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after improvement in diabetes control * Chronic renal failure and on hemodialysis * Genitourinary cancer with ongoing surgical or external beam radiation treatment * Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device * History of bladder-injection of botulinum toxin in the last 12 months * Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by site principal investigator. * Hypersensitivity to drug class * Contraindication to the study drug (solifenacin) including: narrow angle glaucoma, history of gastric retention, history of acute urinary retention requiring catheterization * Current use of a bladder relaxant - permitted to enroll after two week washout * Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the site PI that entry into the treatment protocol is not contraindicated * If on diuretic, dose should be stable for at least 4 weeks * If taking an alpha-blocker, dose should be stable for at least 4 weeks * If taking dutasteride or finasteride, dose should be stable for at least 6 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Non-Inferiority Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Blinded assessor', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 77, 'type': 'ACTUAL'}}

2023-10-25