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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, and Phase IV Study of Efficacy and Safety of Solifenacin Succinate in Patients With Overactive Bladder After TURP or PVP

NCT01747577•Astellas Pharma Korea, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to demonstrate superiority of the solifenacin succinate (treatment) over the placebo (control) based on the change from the baseline in the mean number of urgency episodes per 24 hours after 2 weeks.

Detailed Description

The BPH (benign prostate hyperplasia) patients who have OAB (overactive bladder) after TURP (trans-urethral resection of prostate) or PVP (photoselective vaporization of prostate) will participate in this study. The subjects will be randomized 1:1 to the solifenacin succinate group or to the placebo treatment group. The subjects shall take investigational product each night before sleeping from for four weeks and complete voiding diary. At Week-2 and Week-4 of the treatment, the subjects will be asked to complete the following activities: physical exam, vital signs test, IPSS, OABSS, post-void residual (PVR) test, and uroflowmetry, and will be asked to answer the BSW, (Benefit, Satisfaction and Willingness to Continue Questions) questionnaire.

Eligibility

Age

50 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Screening
•* Patients who are willing and able to accurately complete the voiding diary, IPSS, and OABSS
•* Patients who have been diagnosed with BPH and are scheduled to receive TURP or PVP
•Randomization (after TURP or PVP)
•* Patients who have been diagnosed with OAB by the investigators
•* Patients who underwent catheter removal 5±2 days beforehand and will have more than an average of three urgency episodes per 24 hrs and more than an average of eight micturitions per 24 hrs in a row before Visit 3, as recorded in the voiding diary
•* Patients who will score more than 5 in questions 2, 4, and 7, which are on the storage symptoms in IPSS
•* Patients who will score more than 4 in question 3 and more than 5 in the OABSS
•* Patients who have not been treated with any medication for overactive bladder (OAB) symptoms 14 days before the randomization

Exclusion Criteria

•Screening
•* Patients who have been diagnosed with prostate cancer or bladder cancer and who have a present or resolved malignant disease in any pelvic organ
•* Patients who have neurological diseases that affect micturition and can cause neurogenic bladder disease such as multiple sclerosis, Parkinson's disease, severe cerebral arteriosclerosis, dementia, stroke, or myelitis
•* Patients who have had serious adverse events or are hypersensitive to anticholinergics
•* Patients who have a severe gastrointestinal obstruction disease such as toxin megacolon, ulcerative colitis, intestinal atonia, paralytic ileus, and gastric retention
•* Patients who have been diagnosed with severe myasthenia
•* Patients who have been diagnosed with narrow-angle glaucoma
•* Patients who have serious hepatic impairment (child class C)
•* Patients who are being treated with a CYP3A4 inhibitor (e.g., Ketoconazole)
•* Patients who have severe renal impairment or who are undergoing hemodialysis
+23 more criteria

Locations (1)

Seoul, South Korea

Key Dates

Start Date

December 4, 2012

Primary Completion Date

October 24, 2013

Completion Date

October 24, 2013

Last Updated

November 7, 2024

Enrollment

ACTUAL participants

Conditions

Overactive BladderBenign Prostate HyperplasiaTransurethral Resection of ProstatePhotoselective Vaporization Prostatectomy

Interventions

Solifenacin Succinate

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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