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

• Sponsor: Timothy Boone, MD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01457573
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 33
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Drug: Tamsulosin; Drug: Solifenacin	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• 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: Oct 1, 2011
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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.

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 Names: 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 Names: solifenacin succinate, VESIcare®, Vesicare®

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [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.

2. Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [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.

3. Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. [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.

4. 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 [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.

5. Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 [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.

6. 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 [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.

7. 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 [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.

8. Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 [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.

9. Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Methodist Hospital System	Houston	Texas	United States	77030

Sponsors and Collaborators

• Timothy Boone, MD, PhD
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Timothy Boone, MD,PhD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
• Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. Epub 2006 Feb 17. Review.
• Jacobs BL, Smaldone MC, Tyagi V, Philips BJ, Jackman SV, Leng WW, Tyagi P. Increased nerve growth factor in neurogenic overactive bladder and interstitial cystitis patients. Can J Urol. 2010 Feb;17(1):4989-94.
• Kaplan SA, Goldfischer ER, Steers WD, Gittelman M, Andoh M, Forero-Schwanhaeuser S. Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes. Aging Male. 2010 Jun;13(2):100-7. doi: 10.3109/13685530903440408.
• Kaplan SA, Roehrborn CG, Chancellor M, Carlsson M, Bavendam T, Guan Z. Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Symptom Score. BJU Int. 2008 Nov;102(9):1133-9. doi: 10.1111/j.1464-410X.2008.07761.x. Epub 2008 May 26.
• Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. Erratum in: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.
• Kaplan SA. New data on Tolterodine: Do recent findings dispel questions about treating overactive bladder in men? Eur Urology 2007; Suppl 6: 10-16.
• Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20.
• Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int. 2009 Jun;103(12):1668-72. doi: 10.1111/j.1464-410X.2009.08380.x. Epub 2009 Feb 11.
• Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol. 2008 Jun;179(6):2270-4. doi: 10.1016/j.juro.2008.01.146. Epub 2008 Apr 18.
• McVary KT. 2010 AUA Benign Prostatic Hyperplasia Clinical Guidelines. Panel Chair, AUA News 2010; 15 (3) 10 - 11.
• Yokoyama T, Kumon H, Nagai A. Correlation of urinary nerve growth factor level with pathogenesis of overactive bladder. Neurourol Urodyn. 2008;27(5):417-20.

• Responsible Party: Timothy Boone, MD, PhD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01457573
• Other Study ID Numbers: Pro00006253; IRB# 0711-0124
• First Posted: Oct 24, 2011
• Last Update Posted: Apr 2, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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; Tamsulosin; Solifenacin Succinate

Study Results

Participant Flow

Recruitment Details	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.

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

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 20%
>=65 years	8 80%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Region of Enrollment (participants) [Number]
United States	10 100%
Baseline Post-void residual (PVR) of urine (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	53.89 (51.74)
Baseline Maximum urinary flow rate (ml/s) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml/s]	18.71 (9.27)
Baseline International Prostate Symptom Score (IPSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.2 (5.07)
Baseline Patient Perception of Urgency Score (PPUS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.5 (0.85)
Baseline Perception of Bladder Condition (PBC) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.5 (0.85)
Baseline International Consultation on Incontinence Mod. Questions-Male Lower Urinary Tract Symptoms (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	67.2 (21.04)
Baseline International Consultation on Incontinence Mod. Questions Lower Urinary Tract Symptoms QoL (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	122.6 (59.53)
Baseline Urinary Nerve Growth Factor (pg/ml)/Cr (mg/dl) (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	34.20 (56.69)
Baseline Urinary Nerve Growth Factor (pg/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/ml]	37.10 (21.24)

Outcome Measures

1. Primary Outcome

Title	Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12
Description	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.
Time Frame	Change from baseline to week 12 (3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [pg/ml]	-10.9 (22.81)

2. Primary Outcome

Title	Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)
Description	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.
Time Frame	change from baseline score to Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Characteristics
Arm/Group Description	Men > 50 years old with symptomatic LUTS (IPSS > 8), PSA < 10, PVR < 150 mls and maximum urinary flow rate > 10 mls/sec could enter the trial.
Measure Participants	10
Mean (Standard Deviation) [ratio]	-19.61 (13.21)

3. Secondary Outcome

Title	Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	-6.90 (90.58)
Change at Month 2	-10.00 (60.84)
Change at Month 3	-3.60 (92.71)

4. Secondary Outcome

Title	Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	-3.20 (6.37)
Change at Month 2	-3.90 (9.16)
Change at Month 3	-4.70 (9.38)

5. Secondary Outcome

Title	Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	-2.00 (8.82)
Change at Month 2	-5.30 (6.40)
Change at Month 3	-7.33 (6.98)

6. Secondary Outcome

Title	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
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	0.00 (0.67)
Change at Month 2	0.30 (0.67)
Change at Month 3	0 (1.41)

7. Secondary Outcome

Title	Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	1.29 (1.25)
Change at Month 2	0.29 (1.11)
Change at Month 3	0.00 (0.82)

8. Secondary Outcome

Title	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
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	-22.40 (16.98)
Change at Month 2	-22.20 (16.88)
Change at Month 3	-29.8 (25.97)

9. Secondary Outcome

Title	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
Description	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.
Time Frame	Change from baseline to months 1, 2 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	34.60 (37.61)
Change at Month 2	38.30 (33.15)
Change at Month 3	-9.00 (37.59)

10. Secondary Outcome

Title	Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8
Description	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.
Time Frame	Change from baseline to Mo.1/Wk4 and Mo.2/Wk8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg
Arm/Group Description	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.
Measure Participants	10
Change at Month 1	11.17 (22.68)
Change at Month 2	15.64 (38.76)

11. Secondary Outcome

Title	Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.
Description	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.
Time Frame	change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baseline Characteristics
Arm/Group Description	Men > 50 years old with symptomatic LUTS (IPSS > 8), PSA < 10, PVR < 150 mls and maximum urinary flow rate > 10 mls/sec could enter the trial.
Measure Participants	10
Change at Month 1	-21.85 (14.23)
Change at Month 2	-20.56 (18.96)

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study medications.
Arm/Group Title	Participant Flow
Arm/Group Description	10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial.
All Cause Mortality
	Participant Flow
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Participant Flow
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Participant Flow
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Ear and labyrinth disorders
tinnitus	1/10 (10%)	1
Eye disorders
blurred vision	1/10 (10%)	1
Gastrointestinal disorders
bloating	1/10 (10%)	1
constipation	1/10 (10%)	2
indigestion	1/10 (10%)	1
General disorders
Fatigue	1/10 (10%)	1
malaise	1/10 (10%)	1
Nervous system disorders
decreased memory	1/10 (10%)	1
Renal and urinary disorders
urinary frequency	1/10 (10%)	1
Reproductive system and breast disorders
reduced ejaculation	1/10 (10%)	1
Skin and subcutaneous tissue disorders
dry mouth	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.