Clinical TrialID 5336

Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

NCT01747577

Overactive Bladder|Benign Prostate Hyperplasia|Transurethral Resection of Prostate|Photoselective Vaporization Prostatectomy

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
5336
Evidence Id
5336
Core Evidence Id
5336
Source Clinical Trial Id
5322
Herb2 Clinical Trial Id
HBCT005322
Nct Id
NCT01747577
Title
Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)
Status
Completed
Phase
Phase 4
Study Result
No
Study Condition
Overactive Bladder|Benign Prostate Hyperplasia|Transurethral Resection of Prostate|Photoselective Vaporization Prostatectomy
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Solifenacin Succinate|DRUG: Placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
Male
Age
Adult, Older_Adult
Enrollment
68
Outcome Measure
Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2, Baseline and at week 2
Sponsor Collaborator
Astellas Pharma Korea, Inc.
Funded By
INDUSTRY
Location
Soul, Korea, Republic of
Other Id
VC-OAB-12-01
Start Date
2012-12-04
Primary Completion Date
2013-10-24
Completion Date
2013-10-24
First Posted
2012-12-11
Results First Posted
Last Update Posted
2022-07-27
Study Document
Study Url
https://clinicaltrials.gov/study/NCT01747577
Title Cn
Title En
Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)
Bilingual Status
semi_complete