Phase 4
N=10
Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
Lower Urinary Tract Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT01457573 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 — -10.9 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tamsulosin (Drug); Solifenacin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Timothy Boone, MD, PhD
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 |
-10.9 | — |
| PRIMARY Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr) |
-19.61 | — |
| SECONDARY Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
-6.90; -10.00; -3.60 | — |
| SECONDARY Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
-3.20; -3.90; -4.70 | — |
| SECONDARY Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. |
-2.00; -5.30; -7.33 | — |
| SECONDARY Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
0.00; 0.30; 0 | — |
| SECONDARY Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
1.29; 0.29; 0.00 | — |
| SECONDARY Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
-22.40; -22.20; -29.8 | — |
| SECONDARY Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
34.60; 38.30; -9.00 | — |
| SECONDARY Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 |
11.17; 15.64 | — |
| SECONDARY Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. |
-21.85; -20.56 | — |
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, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.
Eligibility Criteria
Inclusion Criteria
- Men > 45 years old with symptomatic LUTS (clinical benign prostatic hypertrophy/BPH)
- International Prostate Symptom Score (IPSS) > 8
- PSA 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
Data sourced from ClinicalTrials.gov (NCT01457573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.