ID

25680

Description

Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00584090

Link

https://clinicaltrials.gov/show/NCT00584090

Keywords

Versions (1)
  1. 9/9/17 9/9/17 -
Uploaded on

September 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Urinary Incontinence NCT00584090

English

Eligibility Urinary Incontinence NCT00584090

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. outpatients with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnosis criteria.
Description

Outpatients | Parkinson Disease

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0030567
2. age 30 years to 80 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. stable dose of antiparkinsonian medication 4 weeks prior to study entry.
Description

Antiparkinson Agents Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
4. patients must score 18 or higher on the updrs scale and 1.0 to 2.5 on the modified hoehn and yahr scale.
Description

Unified Parkinson's Disease Rating Scale Questionnaire | Modified Hoehn and Yahr Scale score

Data type

boolean

Alias
UMLS CUI [1]
C3639721
UMLS CUI [2]
C4274318
5. women of child-bearing potential must use a reliable method of contraception.
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
6. must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
Description

Urinary Incontinence Symptoms | Urination Quantity times/day | Incontinence Episode Quantity times/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0042024
UMLS CUI [1,2]
C1457887
UMLS CUI [2,1]
C0042034
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0439511
UMLS CUI [3,1]
C0042024
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0456698
7. patients must have evidence of normal psa and urodynamic tests within the last 12 months.
Description

Prostate specific antigen normal | Urodynamic studies normal

Data type

boolean

Alias
UMLS CUI [1]
C0580554
UMLS CUI [2]
C0580523
8. clearance from the patient's urologist or internist who has examined the patient within the last 12-months.
Description

Renal clearance Physical Examination Urologist | Renal clearance Physical Examination Internist

Data type

boolean

Alias
UMLS CUI [1,1]
C0699829
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0260314
UMLS CUI [2,1]
C0699829
UMLS CUI [2,2]
C0031809
UMLS CUI [2,3]
C0278602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any illness that in the investigator's opinion preclude participation in this study.
Description

Illness Study Subject Participation Status Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
2. pregnancy or lactation.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. concurrent participation in another clinical study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
4. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini mental status exam score less than 24).
Description

Dementia Preventing Informed Consent | Mental disorders Preventing Informed Consent | Mini-mental state examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3]
C0451306
5. legal incapacity or limited legal capacity.
Description

Legal capacity Lacking | Legal capacity Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
6. presence of severe renal disease (bun 50% greater than normal).
Description

Kidney Disease Severe | Blood urea nitrogen increased

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0151539
7. presence of major hepatic impairment.
Description

Hepatic impairment Major

Data type

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205164
8. currently taking ketaconazole (anti-fungal) or any cyp3a4 inhibitor.
Description

Ketoconazole Antifungal | CYP3A4 Inhibitors

Data type

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0003308
UMLS CUI [2]
C3850053
9. any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
Description

Bladder outflow obstruction | Gastrointestinal obstruction

Data type

boolean

Alias
UMLS CUI [1]
C0403654
UMLS CUI [2]
C0236124
10. history of controlled narrow angle glaucoma.
Description

Angle Closure Glaucoma Controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0017605
UMLS CUI [1,2]
C2911690
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Similar models

Eligibility Urinary Incontinence NCT00584090

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Parkinson Disease
Item
1. outpatients with idiopathic pd according to the uk parkinson's disease society brain bank clinical diagnosis criteria.
boolean
C0029921 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
Age
Item
2. age 30 years to 80 years.
boolean
C0001779 (UMLS CUI [1])
Antiparkinson Agents Dose Stable
Item
3. stable dose of antiparkinsonian medication 4 weeks prior to study entry.
boolean
C0003405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Unified Parkinson's Disease Rating Scale Questionnaire | Modified Hoehn and Yahr Scale score
Item
4. patients must score 18 or higher on the updrs scale and 1.0 to 2.5 on the modified hoehn and yahr scale.
boolean
C3639721 (UMLS CUI [1])
C4274318 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
5. women of child-bearing potential must use a reliable method of contraception.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Urinary Incontinence Symptoms | Urination Quantity times/day | Incontinence Episode Quantity times/week
Item
6. must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
boolean
C0042024 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0042034 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0439511 (UMLS CUI [2,3])
C0042024 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0456698 (UMLS CUI [3,4])
Prostate specific antigen normal | Urodynamic studies normal
Item
7. patients must have evidence of normal psa and urodynamic tests within the last 12 months.
boolean
C0580554 (UMLS CUI [1])
C0580523 (UMLS CUI [2])
Renal clearance Physical Examination Urologist | Renal clearance Physical Examination Internist
Item
8. clearance from the patient's urologist or internist who has examined the patient within the last 12-months.
boolean
C0699829 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0260314 (UMLS CUI [1,3])
C0699829 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0278602 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Illness Study Subject Participation Status Excluded
Item
1. any illness that in the investigator's opinion preclude participation in this study.
boolean
C0221423 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
2. pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
3. concurrent participation in another clinical study.
boolean
C2348568 (UMLS CUI [1])
Dementia Preventing Informed Consent | Mental disorders Preventing Informed Consent | Mini-mental state examination
Item
4. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini mental status exam score less than 24).
boolean
C0497327 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0451306 (UMLS CUI [3])
Legal capacity Lacking | Legal capacity Limited
Item
5. legal incapacity or limited legal capacity.
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Kidney Disease Severe | Blood urea nitrogen increased
Item
6. presence of severe renal disease (bun 50% greater than normal).
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0151539 (UMLS CUI [2])
Hepatic impairment Major
Item
7. presence of major hepatic impairment.
boolean
C0948807 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Ketoconazole Antifungal | CYP3A4 Inhibitors
Item
8. currently taking ketaconazole (anti-fungal) or any cyp3a4 inhibitor.
boolean
C0022625 (UMLS CUI [1,1])
C0003308 (UMLS CUI [1,2])
C3850053 (UMLS CUI [2])
Bladder outflow obstruction | Gastrointestinal obstruction
Item
9. any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
boolean
C0403654 (UMLS CUI [1])
C0236124 (UMLS CUI [2])
Angle Closure Glaucoma Controlled
Item
10. history of controlled narrow angle glaucoma.
boolean
C0017605 (UMLS CUI [1,1])
C2911690 (UMLS CUI [1,2])
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