ID

36132

Beschrijving

We will conduct a two-site, randomized controlled trial to assess the efficacy of motor skill-based behavioral therapy (PFME) to treat urinary symptoms in adults with Parkinson Disease (PD). After stratification by urinary incontinence 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. ODM derived from: https://clinicaltrials.gov/show/NCT01520948

Link

https://clinicaltrials.gov/show/NCT01520948

Trefwoorden

Versies (2)
  1. 17-04-19 17-04-19 -
  2. 17-04-19 17-04-19 -
Houder van rechten

Atlanta VA Medical Center

Geüploaded op

17 april 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease (BETTUR PD) NCT01520948

Engels

Eligibility

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient with clinical diagnosis of parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
Beschrijving

Diagnosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0030567
UMLS CUI [1,3]
C1301908
UMLS CUI [1,4]
C1704211
UMLS CUI [1,5]
C0026650
Patient with ≥ 4 weekly episodes of urinary incontinence and at least one episode per week associated with feelings of urgency
Beschrijving

urgency is defined as the complaint of a sudden compelling desire to void which is difficult to defer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042024
UMLS CUI [1,2]
C0332174
UMLS CUI [2,1]
C0085606
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0332174
Patient is willing to attend clinic visits
Beschrijving

Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008952
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C0600109
Patient is willing to keep 7-day bladder diaries throughout the study period
Beschrijving

Protocol behaviour

Datatype

boolean

Alias
UMLS CUI [1,1]
C2216446
UMLS CUI [1,2]
C3273494
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient with significant cognitive impairment, as indicated by a montreal cognitive assessment (moca) score of < 18.
Beschrijving

Cognitive impairment

Datatype

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2]
C4721272
Patient is not able to produce an interpretable 7-day bladder diary at baseline
Beschrijving

Protocol behaviour

Datatype

boolean

Alias
UMLS CUI [1,1]
C2216446
UMLS CUI [1,2]
C3273494
UMLS CUI [1,3]
C2347804
UMLS CUI [1,4]
C4048706
Patient with previous intensive PFME training
Beschrijving

PFME = motor skill-based behavioral therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004933
UMLS CUI [1,2]
C0237543
UMLS CUI [1,3]
C1514463
Patient with clinically significant depression as measured by a geriatric depression scale-short form score ≥ 10 which could affect motivation to fully engage in the intervention
Beschrijving

Depression

Datatype

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0026605
UMLS CUI [1,4]
C2348568
UMLS CUI [2]
C2919385
Patient uses an indwelling urinary catheter
Beschrijving

Indwelling urinary catheter

Datatype

boolean

Alias
UMLS CUI [1]
C0521197
Patient with 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
Beschrijving

Bladder outlet obstruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0447585
UMLS CUI [1,2]
C0028778
UMLS CUI [2]
C0150397
UMLS CUI [3,1]
C0080274
UMLS CUI [3,2]
C0429770
UMLS CUI [3,3]
C0041618
UMLS CUI [4]
C0200008
Patient with severe uterine prolapse past the vaginal introitus
Beschrijving

Gynecological conditions

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042140
UMLS CUI [1,2]
C0458952
Patient with poorly controlled diabetes defined by a hemoglobin a1c (hgba1c) of >8.0%
Beschrijving

Diabetes

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0474680
chronic renal failure and on hemodialysis
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C0019004
Patient with poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam
Beschrijving

Cardio-pulmonary diseases

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C3853134
Patient with genitourinary cancer with ongoing surgical or external beam radiation treatment
Beschrijving

Genitourinary cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0751569
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1707479
UMLS CUI [2,1]
C0751569
UMLS CUI [2,2]
C1517033
UMLS CUI [2,3]
C1707479
Patient has any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
Beschrijving

Unstable health condition

Datatype

boolean

Alias
UMLS CUI [1,1]
C4062077
UMLS CUI [1,2]
C0019993
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C4062077
UMLS CUI [2,2]
C0011065
UMLS CUI [2,3]
C1517001
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Similar models

Eligibility

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Diagnosis
Item
Patient with clinical diagnosis of parkinson's disease determined by a board-certified neurologist with specialty training in movement disorders
boolean
C0011900 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1301908 (UMLS CUI [1,3])
C1704211 (UMLS CUI [1,4])
C0026650 (UMLS CUI [1,5])
Urinary incontinence
Item
Patient with ≥ 4 weekly episodes of urinary incontinence and at least one episode per week associated with feelings of urgency
boolean
C0042024 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0085606 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Compliance
Item
Patient is willing to attend clinic visits
boolean
C0008952 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Protocol behaviour
Item
Patient is willing to keep 7-day bladder diaries throughout the study period
boolean
C2216446 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Cognitive impairment
Item
Patient with significant cognitive impairment, as indicated by a montreal cognitive assessment (moca) score of < 18.
boolean
C0338656 (UMLS CUI [1])
C4721272 (UMLS CUI [2])
Protocol behaviour
Item
Patient is not able to produce an interpretable 7-day bladder diary at baseline
boolean
C2216446 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C4048706 (UMLS CUI [1,4])
Prior PFME- Training
Item
Patient with previous intensive PFME training
boolean
C0004933 (UMLS CUI [1,1])
C0237543 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
Depression
Item
Patient with clinically significant depression as measured by a geriatric depression scale-short form score ≥ 10 which could affect motivation to fully engage in the intervention
boolean
C1269683 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0026605 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C2919385 (UMLS CUI [2])
Indwelling urinary catheter
Item
Patient uses an indwelling urinary catheter
boolean
C0521197 (UMLS CUI [1])
Bladder outlet obstruction
Item
Patient with 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
boolean
C0447585 (UMLS CUI [1,1])
C0028778 (UMLS CUI [1,2])
C0150397 (UMLS CUI [2])
C0080274 (UMLS CUI [3,1])
C0429770 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0200008 (UMLS CUI [4])
Gynecological conditions
Item
Patient with severe uterine prolapse past the vaginal introitus
boolean
C0042140 (UMLS CUI [1,1])
C0458952 (UMLS CUI [1,2])
Diabetes
Item
Patient with poorly controlled diabetes defined by a hemoglobin a1c (hgba1c) of >8.0%
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Renal function
Item
chronic renal failure and on hemodialysis
boolean
C0022661 (UMLS CUI [1,1])
C0019004 (UMLS CUI [1,2])
Cardio-pulmonary diseases
Item
Patient with poorly controlled congestive heart failure or poorly controlled chronic obstructive pulmonary disease on physical exam
boolean
C0018802 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Genitourinary cancer
Item
Patient with genitourinary cancer with ongoing surgical or external beam radiation treatment
boolean
C0751569 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1707479 (UMLS CUI [1,3])
C0751569 (UMLS CUI [2,1])
C1517033 (UMLS CUI [2,2])
C1707479 (UMLS CUI [2,3])
Unstable health condition
Item
Patient has any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
boolean
C4062077 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C4062077 (UMLS CUI [2,1])
C0011065 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
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