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

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).

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.

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