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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soonchunhyang University Hospital
• Treatments: Solifenacin Succinate; Tamsulosin

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