Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

NCT03149809 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: N2293-I
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 4

Brief 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

Overactive Bladder; Parkinson Disease

Keywords

Urinary incontinence; Parkinson disease; Overactive urinary bladder; Nocturia

Outcome Measures

Primary Outcomes (1)

• ICIQ-OAB Questionnaire

  The ICIQ-OAB questionnaire is a 4-question assessment of OAB symptoms and the degree to which they bother the respondent (urgency, frequency, nocturia, UI).

  ICIQ-OAB Symptom score at 12 weeks

Secondary Outcomes (2)

• Bladder Diary

  Incontinence episodes per day at 12 weeks

• ICIQ-OAB QOL

  ICIQ-OAB QOL score at 12 weeks

Study Arms (2)

Behavioral therapy

ACTIVE COMPARATOR

Pelvic floor muscle exercise-based behavioral therapy

Behavioral: Pelvic floor muscle exercise-based behavioral therapy

Drug Therapy

ACTIVE COMPARATOR

Daily solifenacin drug therapy

Drug: solifenacin

Interventions

solifenacin DRUG

Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors

Also known as: Vesicare

Drug Therapy

Pelvic floor muscle exercise-based behavioral therapy BEHAVIORAL

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

Behavioral therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (4)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• Vaughan CP, Morley JF, Lehosit J, McGwin G, Muirhead L, Khakharia A, Johnson TM 2nd, Evatt ML, Sergent T, Burgio KL, Markland AD. Behavioral Compared With Drug Therapy for Overactive Bladder Symptoms in Parkinson Disease: A Randomized Noninferiority Trial. JAMA Neurol. 2025 Sep 1;82(9):925-931. doi: 10.1001/jamaneurol.2025.1904.

  PMID: 40658410 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Parkinson Disease; Urinary Incontinence; Nocturia

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: E. Camille Vaughan, MD, MS
• Organization: Atlanta VA Health Care System

elizabeth.vaughan2@va.gov

404 315 4100

Study Officials

• Elizabeth Camille Vaughan, MD MS

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Non-Inferiority Trial

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 11, 2017
• Study Start: March 1, 2018
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4)