Overview

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