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The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01533597
First Posted: February 15, 2012
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kwang-Woo Lee, MD, Soonchunhyang University Hospital
  Purpose
The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

Condition Intervention Phase
Overactive Bladder Drug: Solifenacin Drug: Solifenacin plus Tamsulosin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by Kwang-Woo Lee, MD, Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Change in Mean Number of Micturition Episodes Per 24 Hours [ Time Frame: at week 24 relative to baseline ]

Secondary Outcome Measures:
  • Numeric Change of Urgency Episodes Per 24 Hours [ Time Frame: at week 24 relative to baseline ]
  • Change in Total Score of OABSS [ Time Frame: at week 24 relative to baseline ]
    Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)

  • Change in Score of IPSS [ Time Frame: at week 24 relative to baseline ]
    Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.

  • Change of PVR [ Time Frame: at week 24 relative to baseline ]
    Change from baseline in Post-Void Residual (PVR) volume

  • Change of Qmax [ Time Frame: at week 24 relative to baseline ]
    maximal urinary flow rate (Qmax) assessed by uroflowmetry


Enrollment: 70
Study Start Date: December 2010
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Solifenacin Drug: Solifenacin
Solifenacin (5mg, qd, oral)
Other Name: Vesicare
Experimental: Solifenacin plus Tamsulosin Drug: Solifenacin plus Tamsulosin
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Other Names:
  • Vesicare
  • Harnal

Detailed Description:

Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia.

The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively.

Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.

  Eligibility

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged 20 ≤ and < 70 years
  • History of OAB symptoms for ≥ 3 months
  • International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
  • An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary

Exclusion Criteria:

  • Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine
  • Any condition that would contraindicate their usage of anticholinergics or alpha blockers
  • History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation)
  • History of stress urinary incontinence or urinary retention
  • History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
  • Pregnant or nursing women
  • Current urinary tract infection
  • Neurological bladder dysfunction
  • Treatment with drugs that may interfere with CYP3A4 metabolic function
  • Significant hepatic or renal disease
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01533597


Locations
Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Kwang Woo Lee, Ph.D Soonchunhyang University Hospital
  More Information

Responsible Party: Kwang-Woo Lee, MD, Clinical Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01533597     History of Changes
Other Study ID Numbers: Bomnal study
First Submitted: February 2, 2012
First Posted: February 15, 2012
Results First Submitted: January 11, 2015
Results First Posted: January 27, 2015
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Kwang-Woo Lee, MD, Soonchunhyang University Hospital:
Overactive bladder
Solifenacin succinate
Tamsulosin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tamsulosin
Solifenacin Succinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents