A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
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ClinicalTrials.gov Identifier: NCT00699049 |
Recruitment Status :
Completed
First Posted : June 17, 2008
Last Update Posted : January 7, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Bladder, Overactive | Drug: Alpha blocker Drug: placebo Drug: solifenacin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Alpha blocker and placebo |
Drug: Alpha blocker
oral Drug: placebo oral |
Experimental: Alpha blocker and solifenacin |
Drug: Alpha blocker
oral Drug: solifenacin oral
Other Names:
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- Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ]
- Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ]
- Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ]
- Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency ( >8 micturitions per 24 hours)
- On a stable dose of tamsulosin for at least 1 month
Exclusion Criteria:
- Previous history of acute urinary retention
- Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
- Symptomatic acute urinary tract infection (UTI) during the screening period
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
- A 5-alpha reductase inhibitor if started less than 3 months prior to screening
- Patients with previous urethral, prostate or bladder neck surgery

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699049
Korea, Republic of | |
Cheonan, Korea, Republic of | |
Pusan, Korea, Republic of | |
Seoul, Korea, Republic of |
Study Chair: | Central Contact | Astellas Pharma Inc |
Responsible Party: | KYU-SUNG LEE, professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00699049 |
Other Study ID Numbers: |
SMK-1 |
First Posted: | June 17, 2008 Key Record Dates |
Last Update Posted: | January 7, 2016 |
Last Verified: | January 2016 |
Alpha blocker Tamsulosin Solifenacin Overactive Bladder Urgency incontinence |
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Solifenacin Succinate Adrenergic alpha-Antagonists Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Adrenergic Antagonists Adrenergic Agents |