Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-01-31

Brief Summary

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To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

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Detailed Description

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Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

Conditions

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Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Tamsulosin alone

Group Type PLACEBO_COMPARATOR

Tamsulosin hydrochloride

Intervention Type DRUG

oral

2. Tamsulosin + solifenacin (low dose)

Group Type EXPERIMENTAL

Tamsulosin hydrochloride

Intervention Type DRUG

oral

Solifenacin succinate

Intervention Type DRUG

oral

3. Tamsulosin + solifenacin (high dose)

Group Type ACTIVE_COMPARATOR

Tamsulosin hydrochloride

Intervention Type DRUG

oral

Solifenacin succinate

Intervention Type DRUG

oral

Interventions

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Tamsulosin hydrochloride

oral

Intervention Type DRUG

Solifenacin succinate

oral

Intervention Type DRUG

Other Intervention Names

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Harnal YM617 Vesicare YM905

Eligibility Criteria

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Inclusion Criteria

* Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
* Patients with urgency episodes and frequent micturitions
* Written informed consent has been obtained
* Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume \< 50 mL

Exclusion Criteria

* Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
* Patients with obvious stress urinary incontinence
* Patients with complications or who have a past history of a bladder tumor
* Patients with urethral stricture or bladder neck stenosis
* Patients with a history of surgery causing damage to the pelvic plexus
* Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
* Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No