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

Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study

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).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Solifenacin; Drug: Solifenacin plus Tamsulosin

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of, 420-767
      • Soonchunhyang University Bucheon Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Solifenacin	Drug: Solifenacin; Solifenacin (5mg, qd, oral); Other Names: Vesicare
EXPERIMENTAL: Solifenacin plus Tamsulosin	Drug: Solifenacin plus Tamsulosin; Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral); Other Names: Vesicare; Harnal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Mean Number of Micturition Episodes Per 24 Hours	at week 24 relative to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Change of Urgency Episodes Per 24 Hours		at week 24 relative to baseline
Change in Total Score of OABSS	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)	at week 24 relative to baseline
Change in Score of IPSS	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.	at week 24 relative to baseline
Change of PVR	Change from baseline in Post-Void Residual (PVR) volume	at week 24 relative to baseline
Change of Qmax	maximal urinary flow rate (Qmax) assessed by uroflowmetry	at week 24 relative to baseline

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Kwang Woo Lee, Ph.D, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 24, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Tamsulosin; Overactive bladder; Solifenacin succinate
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; 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: Bomnal study