Phase 4
N=70
The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01533597 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Change in Mean Number of Micturition Episodes Per 24 Hours — -1.9; -2.2 episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Solifenacin (Drug); Solifenacin plus Tamsulosin (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Soonchunhyang University Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Number of Micturition Episodes Per 24 Hours |
-1.9; -2.2 | — |
| SECONDARY Numeric Change of Urgency Episodes Per 24 Hours |
-2.4; -2.1 | — |
| SECONDARY Change in Total Score of OABSS |
-3.1; -3.5 | — |
| SECONDARY Change in Score of IPSS |
-7.7; -8.3 | — |
| SECONDARY Change of PVR |
13.2; 10.8 | — |
| SECONDARY Change of Qmax |
1.1; 2.1 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01533597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.