Clinical trial NCT01533597: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Keywords: Overactive bladder
Solifenacin succinate
Tamsulosin
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Mean Number of Micturition Episodes Per 24 Hours
timeFrame: at week 24 relative to baseline
Secondary outcomes:
measure: Numeric Change of Urgency Episodes Per 24 Hours
timeFrame: at week 24 relative to baseline
measure: Change in Total Score of OABSS
timeFrame: at week 24 relative to baseline
measure: Change in Score of IPSS
timeFrame: at week 24 relative to baseline
measure: Change of PVR
timeFrame: at week 24 relative to baseline
measure: Change of Qmax
timeFrame: at week 24 relative to baseline
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Kwang Woo Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: