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Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease (BOSS PD)

Primary Purpose

Overactive Bladder, Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
solifenacin
Pelvic floor muscle exercise-based behavioral therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary incontinence, Parkinson disease, Overactive urinary bladder, Nocturia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, AL
  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Behavioral therapy

Drug Therapy

Arm Description

Pelvic floor muscle exercise-based behavioral therapy

Daily solifenacin drug therapy

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Bladder diary
7-day bladder diary includes daily participant-reported voids and incontinent episodes, with ratings of associated urgency, and wake time and bedtime to assess daytime frequency and nocturia
ICIQ-OAB QOL
Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities

Full Information

First Posted
May 9, 2017
Last Updated
October 23, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03149809
Brief Title
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
Acronym
BOSS PD
Official Title
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 8, 2023 (Actual)
Study Completion Date
September 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The number of persons with Parkinson Disease (PD) in the United States is expected to double by 2030 as the population ages. Importantly, this increase in the prevalence of PD will have greater impact within the Department of Veterans Affairs (VA) because the Veteran population is older than the general population and Veterans with PD are more likely than those without PD to rely solely on VA for their health care. While PD is often characterized by the motor symptoms of the disease (tremor, bradykinesia, rigidity), non-motor symptoms such as urinary symptoms correlate more closely with impaired well-being as the disease progresses. However, the impact of urinary symptoms in PD extends beyond worsened well-being. The urinary symptoms of overactive bladder (OAB), including urgency, frequency, and nocturia, with or without urinary incontinence, are the most common urinary symptoms of PD. OAB symptoms are associated with falls (a cause of increased mortality in PD), with spouse/caregiver stress, and, ultimately with institutionalization, thus it is critical that we optimize the care of urinary symptoms for Veterans with PD. Several studies suggest abnormal central nervous system processing of sensory input from bladder afferent nerves contributes to OAB symptoms in PD, possibly because of delayed recognition of bladder fullness. This mirrors findings in non-PD populations with OAB. In the non-PD OAB population, pelvic floor muscle contractions diminish bladder muscle contraction and recent evidence demonstrates that behavioral training with pelvic floor muscle exercises improves the cortical integration of bladder afferent signals. Pelvic floor muscle exercise-based behavioral therapy for OAB symptoms requires individuals to learn a motor skill and implement an adaptive behavioral strategy to delay the need to void. Because of its effectiveness compared to drug therapy, pelvic floor muscle exercise-based behavioral therapy is recommended first-line in men and women with OAB who do not have PD. However, the most recent clinical guidelines for the treatment of urinary symptoms in PD recommend treatment with anticholinergic drugs. While some anticholinergic drugs are effective in reducing symptoms of OAB, it is important to note that there is a glaring lack of an empirical evidence base to promote these drugs in the setting of PD given that they add to the anticholinergic burden of antiparkinsonian therapy, and may worsen the cognitive and autonomic burdens of the illness. Therefore, randomized controlled trials (RCTs) are needed to optimize treatment paradigms for urinary symptoms in PD. The investigators propose a three-site, RCT conducted at the Atlanta (lead site), Birmingham and Richmond VA's to establish non-inferiority of pelvic floor muscle exercise-based behavioral therapy compared to drug therapy for OAB symptoms in adults with PD. Groups will be stratified by OAB symptom severity, PD motor symptom severity, gender, and site. The investigators will randomize 90 participants in order to complete the study in 80 participants, assuming 85% power and a non-inferiority margin for the OAB symptom score of 15% at 12-weeks. The primary outcome measure will be urinary symptom severity as measured by the International Consultation on Incontinence Questionnaire (ICIQ)-OAB symptom score collected at 3 time points during the study: baseline, 6 weeks, and 12 weeks. The investigators' benchmark for successful treatment will be a 2 point reduction in the ICIQ-OAB symptom score, which corresponds with perceived benefit in preliminary studies of behavioral therapy treatment for OAB symptoms in PD. To evaluate the primary efficacy outcome, the investigators will utilize a random effects mixed model and adjust for baseline OAB symptom score severity. Additionally, in order to better understand central control mechanisms of bladder function, the investigators will determine if domain-specific cognitive function impacts the response to exercise-based behavioral therapy or drug therapy for urinary symptoms. At baseline and 12 weeks, randomized participants will undergo a brief neuropsychological battery. Understanding how domain-specific cognitive function impacts response to treatment may inform new targets for rehabilitation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Parkinson Disease
Keywords
Urinary incontinence, Parkinson disease, Overactive urinary bladder, Nocturia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Non-Inferiority Trial
Masking
Outcomes Assessor
Masking Description
Blinded assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral therapy
Arm Type
Active Comparator
Arm Description
Pelvic floor muscle exercise-based behavioral therapy
Arm Title
Drug Therapy
Arm Type
Active Comparator
Arm Description
Daily solifenacin drug therapy
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle exercise-based behavioral therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
ICIQ-OAB questionnaire
Description
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).
Time Frame
change from baseline in symptom score at 12 weeks within and between groups
Secondary Outcome Measure Information:
Title
Bladder diary
Description
7-day bladder diary includes daily participant-reported voids and incontinent episodes, with ratings of associated urgency, and wake time and bedtime to assess daytime frequency and nocturia
Time Frame
change from baseline in weekly incontinence frequency at 12 weeks within and between groups
Title
ICIQ-OAB QOL
Description
Assessment of quality of life related to the impact of overactive bladder symptoms on daily activities
Time Frame
change from baseline in QOL score at 12 weeks within and between groups

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Camille Vaughan, MD MS
Organizational Affiliation
Atlanta VA Medical and Rehab Center, Decatur, GA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Final data sets underlying publications resulting from the proposed research will be shared outside VA through a de-identified, anonymized Dataset under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

Learn more about this trial

Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

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