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

Soon Chun Hyang University

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin; Drug: Solifenacin plus Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT01533597

Bomnal study

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Solifenacin

Active Comparator group

Treatment:

Drug: Solifenacin

Solifenacin plus Tamsulosin

Experimental group

Treatment:

Drug: Solifenacin plus Tamsulosin