Clinical trial NCT00507455: Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction
Official title: A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate With 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Keywords: Lower Urinary Tract Symptoms
Bladder Outlet Obstruction
Treatment
Solifenacin Succinate
Tamsulosin hydrochloride
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-07-26
Enrollment: 222
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
* BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
* Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
* Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.

Exclusion Criteria:

* History of urinary retention in preceding 12 months
* Current urinary tract infection (UTI) or symptomatic and recurrent UTI of \> 3 episodes within 12 months.
* Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
* Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
* Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1

Primary outcomes:
measure: Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Post Void Residual Volume (PVR)
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline to End of Treatment in Bladder Contractility Index (BCI)
timeFrame: Baseline and Week 12
measure: Change From Baseline to End of Treatment in Percent Bladder Voiding Efficiency (BVE)
timeFrame: Baseline and Week 12
measure: Safety Assessed by Adverse Events (AEs), Electrocardiogram (ECG), Vital Signs, Physical Exam and Laboratory Tests
timeFrame: From first dose to within 30 days after last dose of double blind study medication (up to 16 weeks).
measure: Change From Baseline in International Prostate Symptoms Score (IPSS)
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in IPSS Voiding Score
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in IPSS Storage Score
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC)
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in Number of Micturitions Per 24 Hours
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in Number of Urgency Episodes Per 24 Hours
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in Volume Voided Per Micturition
timeFrame: Baseline and Weeks 2, 4, 8 and 12
measure: Change From Baseline in International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptom (ICIQ MLUTS) Total Symptom Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline in ICIQ-MLUTS Total Symptom Bother Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline in International Consultation on Incontinence Questionnaire - Lower Urinary Tract Symptom Quality of Life (ICIQ-LUTSqol) Symptom Score
timeFrame: Baseline and Weeks 4, 8 and 12
measure: Change From Baseline in ICIQ-LUTSqol Overall Symptom Interference of Life Score
timeFrame: Baseline and Weeks 4, 8 and 12
Other outcomes:
Locations:
city: Homewood
country: United States
state: Alabama
city: La Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Middlebury
country: United States
state: Connecticut
city: New Port Richey
country: United States
state: Florida
city: Coeur d'Alene
country: United States
state: Idaho
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Watertown
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Edegem
country: Belgium
city: Kortrijk
country: Belgium
city: Olomouc
country: Czech Republic
city: Pilsen
country: Czech Republic
city: Prague
country: Czech Republic
city: Aachen
country: Germany
city: Hagenow
country: Germany
city: Landshut
country: Germany
city: Muelheim
country: Germany
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Bialystok
country: Poland
city: Myslowice
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Kaplan SA, He W, Koltun WD, Cummings J, Schneider T, Fakhoury A. Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Eur Urol. 2013 Jan;63(1):158-65. doi: 10.1016/j.eururo.2012.07.003. Epub 2012 Jul 17.