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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Solifenacin Succinate; Tamsulosin

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