Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms (LUTS)
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ClinicalTrials.gov Identifier: NCT01457573 |
Recruitment Status
:
Completed
First Posted
: October 24, 2011
Results First Posted
: April 2, 2018
Last Update Posted
: April 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lower Urinary Tract Symptoms | Drug: Tamsulosin Drug: Solifenacin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial |
Actual Study Start Date : | October 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: One (single arm)
All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg (1 tab) and Solifenacin (Vesicare) 5 mg (1 tab) orally at the same time.
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Drug: Tamsulosin
Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®).
Other Name: tamsulosin hydrochloride, tamsulosin HCl, Flomax®
Drug: Solifenacin
Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.
Other Name: solifenacin succinate, VESIcare®, Vesicare®
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- Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 [ Time Frame: 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) [ Time Frame: 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.
- Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [ Time Frame: Change from baseline to months 1, 2 and 3 ]Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin.
- Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [ Time Frame: Change from baseline to months 1, 2 and 3 ]Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old.
- Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. [ Time Frame: Change from baseline to months 1, 2 and 3 ]The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms.
- 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 [ Time Frame: Change from baseline to months 1, 2 and 3 ]The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin.
- Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [ Time Frame: Change from baseline to months 1, 2 and 3 ]Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome.
- 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 [ Time Frame: Change from baseline to months 1, 2 and 3 ]Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome.
- 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 [ Time Frame: Change from baseline to months 1, 2 and 3 ]Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome.
- Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 [ Time Frame: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8 ]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) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin.
- Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. [ Time Frame: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores ]Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses.

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Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457573
United States, Texas | |
The Methodist Hospital System | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Timothy Boone, MD,PhD | The Methodist Hospital System |
Publications of Results:
Other Publications:
Responsible Party: | Timothy Boone, MD, PhD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT01457573 History of Changes |
Other Study ID Numbers: |
Pro00006253 IRB# 0711-0124 ( Other Identifier: HMRI IRB ) |
First Posted: | October 24, 2011 Key Record Dates |
Results First Posted: | April 2, 2018 |
Last Update Posted: | April 2, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Plan to share data to be determined. |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No | |
Product Manufactured in and Exported from the U.S.: | No |
Additional relevant MeSH terms:
Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Mitogens Tamsulosin Solifenacin Succinate Mitosis Modulators Molecular Mechanisms of Pharmacological Action Adrenergic alpha-1 Receptor Antagonists |
Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |