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

NCT ID: NCT01533597

Last Updated: 2015-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-02-28

Brief Summary

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).

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin

Group Type: ACTIVE_COMPARATOR

Solifenacin

Intervention Type: DRUG

Solifenacin (5mg, qd, oral)

Solifenacin plus Tamsulosin

Group Type: EXPERIMENTAL

Solifenacin plus Tamsulosin

Intervention Type: DRUG

Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Interventions

Solifenacin

Solifenacin (5mg, qd, oral)

Intervention Type: DRUG

Solifenacin plus Tamsulosin

Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Intervention Type: DRUG

Other Intervention Names

Vesicare; Vesicare; Harnal

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Soonchunhyang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kwang-Woo Lee, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwang Woo Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

Bomnal study

Identifier Type: -

Identifier Source: org_study_id