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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533597
• Other study ID #: Bomnal study
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2012
• Last updated: January 24, 2015
• Start date: December 2010
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin
Solifenacin (5mg, qd, oral)
• Solifenacin plus Tamsulosin
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Number of Micturition Episodes Per 24 Hours		at week 24 relative to baseline	No
Secondary	Numeric Change of Urgency Episodes Per 24 Hours		at week 24 relative to baseline	No
Secondary	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	No
Secondary	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	No
Secondary	Change of PVR	Change from baseline in Post-Void Residual (PVR) volume	at week 24 relative to baseline	Yes
Secondary	Change of Qmax	maximal urinary flow rate (Qmax) assessed by uroflowmetry	at week 24 relative to baseline	No