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

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 Month, 2 Month and 3 Month to evaluate: urinary NGF (pg/mL), urine creatinine
(mg/dL), NGF/Cr ratio and patient reported questionnaire outcomes (AUA Symptom Score/IPSS,
Patient Perception of Bladder Condition, Patient Perception of Urge Intensity 'PPIUS', LUTS
Urinary Symptoms and Quality of Life). Each participant is assessed from baseline to Month 3
measurements. Protection of human subjects will be provided through the Houston Methodist
Research Institute Institutional Review Board (see appendix 2). All men will receive morning
dosing with Tamsulosin 0.4 mg (1 tab) and Solifenacin 5 mg (1 tab) orally at the same time.

Inclusion Criteria:

- 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 Criteria:

- 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