Last reviewed · How we verify
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial (LUTS)
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.
Details
| Lead sponsor | Timothy Boone, MD, PhD |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 10 |
| Start date | 2011-10 |
| Completion | 2014-07 |
Conditions
- Lower Urinary Tract Symptoms
Interventions
- Tamsulosin
- Solifenacin
Primary outcomes
- Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 — Change from baseline to week 12 (3 months)
Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. - Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr) — change from baseline score to Month 3
The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses.
Countries
United States