Status:
COMPLETED
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
Lead Sponsor:
Timothy Boone, MD, PhD
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Lower Urinary Tract Symptoms
Eligibility:
MALE
45+ years
Phase:
PHASE4
Brief Summary
A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF...
Detailed Description
Single center, pilot trial, single arm study using once daily dosing of tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Assessments occur at Baseline, 1 Mont...
Eligibility Criteria
Inclusion
- Men \> 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH)
- International Prostate Symptom Score (IPSS) \> 8
- PSA \< 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma)
- Post void residual urine \< 150 mls
- Urinary Flow rate \> 15 mL/sec
Exclusion
- Neurogenic bladder
- Urinary tract infection, Urinary stone(s), Urinary tract tumor
- Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries
- Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months.
- History of cataracts with planned surgery
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01457573
Start Date
October 1 2011
End Date
July 1 2014
Last Update
April 2 2018
Active Locations (1)
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1
The Methodist Hospital System
Houston, Texas, United States, 77030