Clinical trial NCT00771394: Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy
Overactive Bladder
Keywords: Vesicare
Solifenacin succinate
Tamsulosin
Overactive Bladder
BPH
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 638
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in mean number of urgency episodes per 24 hours
timeFrame: at 4, 8, 12 week
Secondary outcomes:
measure: Mean number of micturitions per 24 hrs
timeFrame: at 4, 8, 12 week
measure: Mean number of incontinence episodes per 24 hours
timeFrame: at 4, 8, 12 week
measure: Mean number of micturitions per night
timeFrame: at 4, 8, 12 week
measure: Adverse Events, Laboratory Tests
timeFrame: end of study
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References: