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

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Solifenacin

Solifenacin plus Tamsulosin

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Solifenacin succinate, Tamsulosin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Soonchunhyang University Bucheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Solifenacin

Solifenacin plus Tamsulosin

Arm Description

Outcomes

Primary Outcome Measures

Change in Mean Number of Micturition Episodes Per 24 Hours

Secondary Outcome Measures

Numeric Change of Urgency Episodes Per 24 Hours

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)

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.

Change of PVR

Change from baseline in Post-Void Residual (PVR) volume

Change of Qmax

maximal urinary flow rate (Qmax) assessed by uroflowmetry

Full Information

NCT ID

NCT01533597

First Posted

February 2, 2012

Last Updated

January 24, 2015

Sponsor

Soonchunhyang University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01533597

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Overactive bladder, Solifenacin succinate, Tamsulosin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solifenacin

Arm Type

Active Comparator

Arm Title

Solifenacin plus Tamsulosin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Solifenacin

Other Intervention Name(s)

Vesicare

Intervention Description

Solifenacin (5mg, qd, oral)

Intervention Type

Drug

Intervention Name(s)

Solifenacin plus Tamsulosin

Other Intervention Name(s)

Vesicare, Harnal

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Mean Number of Micturition Episodes Per 24 Hours

Time Frame