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

Condition(s) targeted: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy; Overactive Bladder

Intervention: Tamsulosin hydrochloride (Drug); Solifenacin succinate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Adminstration Department, Email: clinicaltrials_info@jp.astellas.com

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

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in mean number of urgency episodes per 24 hours

Secondary outcome:

Mean number of micturitions per 24 hrs

Mean number of incontinence episodes per 24 hours

Mean number of micturitions per night

Adverse Events, Laboratory Tests

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

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

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

Clinical Development Adminstration Department, Email: clinicaltrials_info@jp.astellas.com

Hokkaido, Japan; Recruiting

Touhoku, Japan; Recruiting

Kantou, Japan; Recruiting

Chubu, Japan; Recruiting

Kansai, Japan; Recruiting

Shikoku, Japan; Recruiting

Chugoku, Japan; Recruiting

Kyushu, Japan; Recruiting

Starting date: October 2008
Ending date: December 2009
Last updated: October 23, 2008