Trial Outcomes & Findings for Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms (NCT NCT01457573)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Change from baseline to week 12 (3 months)

Results posted on

2018-04-02

Participant Flow

Potential participants were approached by the PI and Study Team in an outpatient urology clinic setting between October 2011 and December 2014 for recruitment to the male lower urinary tract symptoms study.

Participant milestones

Participant milestones
Measure	Single Arm (Tamsulosin and Solifenacin) 10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants Men \> 50 years old with urinary frequency symptoms, who entered study not taking any bladder related medications and on study took tamsulosin and solifenacin orally everyday throughout the study with follow-up assessments at Month 1/week 4, Month 2 week 8, and Month 3/week 12.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Baseline Post-void residual (PVR) of urine	53.89 ml STANDARD_DEVIATION 51.74 • n=5 Participants
Baseline Maximum urinary flow rate	18.71 ml/s STANDARD_DEVIATION 9.27 • n=5 Participants
Baseline International Prostate Symptom Score (IPSS)	18.2 units on a scale STANDARD_DEVIATION 5.07 • n=5 Participants
Baseline Patient Perception of Urgency Score (PPUS)	2.5 units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants
Baseline Perception of Bladder Condition (PBC)	3.5 units on a scale STANDARD_DEVIATION 0.85 • n=5 Participants
Baseline International Consultation on Incontinence Mod. Questions-Male Lower Urinary Tract Symptoms	67.2 units on a scale STANDARD_DEVIATION 21.04 • n=5 Participants
Baseline International Consultation on Incontinence Mod. Questions Lower Urinary Tract Symptoms QoL	122.6 units on a scale STANDARD_DEVIATION 59.53 • n=5 Participants
Baseline Urinary Nerve Growth Factor (pg/ml)/Cr (mg/dl)	34.20 ratio STANDARD_DEVIATION 56.69 • n=5 Participants
Baseline Urinary Nerve Growth Factor	37.10 pg/ml STANDARD_DEVIATION 21.24 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg n=10 Participants All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time. Solifenacin (Vesicare) 5 mg orally at the same time.: Drug: Tamsulosin 0.4 mg in combination with Solifenacin 5 mg All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg and Solifenacin (Vesicare) 5 mg orally at the same time.
Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12	-10.9 pg/ml Standard Deviation 22.81

PRIMARY outcome

Timeframe: 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.