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

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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy
• Intervention / Treatment: Drug: Solifenacin succinate; Drug: Tamsulosin hydrochloride

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

• Study Type: Interventional
• Enrollment (Actual): 638
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Chugoku, Japan
  • Hokkaido, Japan
  • Kansai, Japan
  • Kantou, Japan
  • Kyushu, Japan
  • Shikoku, Japan
  • Touhoku, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1. Tamsulosin alone	Drug: Tamsulosin hydrochloride; oral; Other Names: YM617; Harnal
Experimental: 2. Tamsulosin + solifenacin (low dose)	Drug: Solifenacin succinate; oral; Other Names: Vesicare; YM905; Drug: Tamsulosin hydrochloride; oral; Other Names: YM617; Harnal
Active Comparator: 3. Tamsulosin + solifenacin (high dose)	Drug: Solifenacin succinate; oral; Other Names: Vesicare; YM905; Drug: Tamsulosin hydrochloride; oral; Other Names: YM617; Harnal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in mean number of urgency episodes per 24 hours	at 4, 8, 12 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean number of micturitions per 24 hrs	at 4, 8, 12 week
Mean number of incontinence episodes per 24 hours	at 4, 8, 12 week
Mean number of micturitions per night	at 4, 8, 12 week
Adverse Events, Laboratory Tests	end of study

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on JAPIC - enter JapicCTI-R120267 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 13, 2008

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Overactive Bladder; BPH; Tamsulosin; Solifenacin succinate; Vesicare
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Pathological Conditions, Anatomical; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Hypertrophy; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Solifenacin Succinate
• Other Study ID Numbers: 905-JC-001