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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kwang-Woo Lee, MD, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01533597
First received: February 2, 2012
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Change in mean number of micturition episodes per 24 hours [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Numeric change of urgency episodes per 24 hours [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: No ]
  • Change in total score of KHQ [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: No ]
  • Change in total score of OABSS [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: No ]
  • Change in score of IPSS [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: No ]
  • Change of uroflowmetry and PVR [ Time Frame: at week 24 relative to baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: October 2011
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

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Bucheon Hospital
  More Information

No publications provided

Responsible Party: Kwang-Woo Lee, MD, Clinical Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01533597     History of Changes
Other Study ID Numbers: Bomnal study
Study First Received: February 2, 2012
Last Updated: February 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Soonchunhyang University Hospital:
Overactive bladder
Solifenacin succinate
Tamsulosin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 22, 2013