Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT03149809
• Date of registration: 09/05/2017
• Prospective Registration: Yes
• Primary sponsor: VA Office of Research and Development
• Public title: Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease BOSS PD
• Scientific title: Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
• Date of first enrolment: March 1, 2018
• Target sample size: 77
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03149809
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Elizabeth Camille Vaughan, MD MS
• Affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Overactive Bladder

Parkinson Disease

Intervention(s)

Drug: solifenacin

Behavioral: Pelvic floor muscle exercise-based behavioral therapy

Primary Outcome(s)

ICIQ-OAB questionnaire [Time Frame: change from baseline in symptom score at 12 weeks within and between groups]

Secondary Outcome(s)

ICIQ-OAB QOL [Time Frame: change from baseline in QOL score at 12 weeks within and between groups]

Bladder diary [Time Frame: change from baseline in weekly incontinence frequency at 12 weeks within and between groups]

Secondary ID(s)

N2293-I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors