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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01533597

Enrollment

Registered

2012-02-15

Start date

2010-12-31

Completion date

2014-02-28

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Overactive bladder, Solifenacin succinate, Tamsulosin

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.

Interventions

DRUGSolifenacin

Solifenacin (5mg, qd, oral)

DRUGSolifenacin plus Tamsulosin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Participant flow

Participants by arm

Arm	Count
Solifenacin Solifenacin: Solifenacin (5mg, qd, oral)	35
Solifenacin Plus Tamsulosin Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)	35
Total	70

Baseline characteristics

Characteristic	Solifenacin Plus Tamsulosin	Total	Solifenacin
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	4 Participants	3 Participants
Age, Categorical Between 18 and 65 years	34 Participants	66 Participants	32 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 13.8	52.2 years STANDARD_DEVIATION 11.4	52.1 years STANDARD_DEVIATION 8.2
Region of Enrollment Korea, Republic of	35 participants	70 participants	35 participants
Sex: Female, Male Female	35 Participants	70 Participants	35 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 35	2 / 35
serious Total, serious adverse events	0 / 35	0 / 35