Urinary IncontinencePhase 3BETTUR PDNCT01520948
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
A Phase 3 study testing Exercise-based behavioral therapy in people with Urinary Incontinence and Nocturia, run by Atlanta VA Medical Center at 2 sites in United States.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Nocturia
- What is being tested?
- Exercise-based behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
- ≥ 4 weekly episodes of UI and at least one episode per week associated with feelings of urgency, where urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer
- Willingness to attend clinic visits
- Willingness to keep 7-day bladder diaries throughout the study period
Who cannot join
- Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of < 18.
- Inability to produce an interpretable 7-day bladder diary at baseline
- Previous intensive PFME 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
- Bladder outlet obstruction defined as having been prescribed in-and-out catheterization in the past 12 months, having a post-void residual urine volume by bladder ultrasound of ≥ 200 mL or a peak voiding flow rate of ≤ 4 mL/min on a void ≥ 125 mL in volume
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- Severe uterine prolapse past the vaginal introitus
- Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of >8.0%
- Chronic renal failure and on hemodialysis
- Poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam
- Genitourinary cancer with ongoing surgical or external beam radiation treatment
- Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Birmingham VAMC
Birmingham, Alabama, 35233
Atlanta VA Medical Center
Decatur, Georgia, 30033
About this study
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI.
We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group.
Read more
We hypothesize that:
- PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary.
- Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.
- Conditions
- Urinary Incontinence, Nocturia
- Being tested
- Exercise-based behavioral therapy, Behavioral control
- Keywords
- Parkinson disease, Incontinence
- Medical subject headings
- Urinary Incontinence, Nocturia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based behavioral therapyBehavioural
Pelvic floor muscle exercise training, bladder training, fluid management, constipation management
Behavioral controlBehavioural
Mirrored star drawing
| Study group | Role | What they receive |
|---|---|---|
| Exercise-based behavioral therapy | Experimental | Pelvic floor muscle exercise-based behavioral therapy Receives: Behavioral: Exercise-based behavioral therapy |
| Behavioral control | Placebo comparator | Mirrored Star Drawing Receives: Behavioral: Behavioral control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder diary
Measured: 1 week
Secondary outcomes (1)
Quality of Life Questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Camille Vaughan, MD, Atlanta VA Medical Center
- Investigators
- E. Camille Vaughan, MD, MS, Principal investigator, Atlanta VAMC/Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520948
- Sponsor's protocol ID
- D7892W
- Acronym
- BETTUR PD
- Status last verified
- Jan 2018
- First submitted
- 26 Jan 2012
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
- ClinicalTrials.gov ID
- NCT01520948
- Acronym / sponsor ID
- BETTUR PD / D7892W
- Conditions
- Urinary Incontinence, Nocturia
- Keywords
- Parkinson disease, Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Study start
- Sep 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms of tremor, slowness of movement, and stiffness, leading to progressive disability and loss of independence. Lower urinary tract symptoms (LUTS), including urinary incontinence (UI), urgency, and/or nocturia, are common non-motor symptoms that further diminish the already compromised quality of life for adults living with PD. Behavioral interventions for UI - including pelvic floor muscle exercise (PFME) therapy - have proven efficacy in randomized controlled trials and are free of side effects. Exercise-based behavioral therapy for UI requires individuals to learn a motor skill (PFME) and implement an adaptive behavioral strategy that incorporates the PFME to suppress urinary urgency and prevent UI.
We will conduct a two-site, randomized controlled trial to assess the efficacy of PFME-based behavioral therapy to treat urinary symptoms in adults with PD. After stratification by UI severity, PD severity, and gender, a group of 60 subjects (30 in each group) will be randomized to receive behavioral therapy or a behavioral control over 8 weeks in order to achieve a sample size of 50 individuals (25 in each group) who complete the study. A 6-month follow-up is planned in the treatment group.
We hypothesize that:
- PD participants who are randomized to the exercise-based behavioral therapy group (Group A) will report a significant reduction in weekly frequency of UI episodes compared to PD participants in the behavioral control group (Group B). The primary outcome, frequency of UI, will be measured using a seven-day bladder diary.
- Compared to PD participants in Group B, the reduction in UI frequency in Group A will be clinically meaningful as measured by a corresponding improvement on questionnaires of satisfaction and quality of life as well as a decline in other urinary symptoms including urgency and nocturia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise-based behavioral therapy | Experimental | Behavioral: Exercise-based behavioral therapyPelvic floor muscle exercise-based behavioral therapy |
| Behavioral control | Placebo comparator | Behavioral: Behavioral controlMirrored Star Drawing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
- ≥ 4 weekly episodes of UI and at least one episode per week associated with feelings of urgency, where urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer
- Willingness to attend clinic visits
- Willingness to keep 7-day bladder diaries throughout the study period
Key exclusion criteria (12 listed)
- Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of < 18.
- Inability to produce an interpretable 7-day bladder diary at baseline
- Previous intensive PFME 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-based behavioral therapyPelvic floor muscle exercise training, bladder training, fluid management, constipation management | Behavioural | Exercise-based behavioral therapy |
| Behavioral controlMirrored star drawing | Behavioural | Behavioral control |
Primary outcome
Bladder diary
Time frame: 1 week
1 secondary outcome
Quality of Life Questionnaire
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Camille Vaughan, MD, MS principal investigator
Atlanta VAMC/Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise-based behavioral therapy in people with Urinary Incontinence and Nocturia, run by Atlanta VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder diary (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.