Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

Completed · Phase 4

Conditions studied: Lower Urinary Tract Symptoms

In brief

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, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.

Key facts

Study ID

NCT01457573

Run by

Timothy Boone, MD, PhD

People needed

10

Starts

2011-10-01

Expected to finish

2014-07-01

Last updated by the study team

2018-04-02

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Methodist Hospital System — Houston, Texas, United States

Full record on ClinicalTrials.gov

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