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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
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Timothy Boone, MD, PhD, The Methodist Hospital System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lower Urinary Tract Symptoms
Interventions: Drug: Tamsulosin
Drug: Solifenacin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Single Arm (Tamsulosin and Solifenacin)
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study 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.

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      2  20.0% 
>=65 years      8  80.0% 
Age 
[Units: Years]
Mean (Full Range)
 64 
 (48 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      10 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   10 
Baseline Post-void residual (PVR) of urine [1] 
[Units: Ml]
Mean (Standard Deviation)
 53.89  (51.74) 
[1] PVR is the measure of urine measured in milliliters (ml), by an ultrasound over the abdomen, to measure how much urine remains in the bladder after it is completely empty following urodynamic measurements. Urodynamics is the test done right before the PVR to measure how fast and how much, volume of urine is emptied from the bladder. These measurements help identify issues related to enlarged prostate or other issue.
Baseline Maximum urinary flow rate [1] 
[Units: Ml/s]
Mean (Standard Deviation)
 18.71  (9.27) 
[1] Max urinary flow rate in ml/sec measured by urodynamics at baseline. An average rate in males is 21 ml/sec (ages 14-45 years-old) and 12 ml/sec in males (ages 46-65 years-old).
Baseline International Prostate Symptom Score (IPSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.2  (5.07) 
[1] IPSS is a questionnaire, max of 35 points, none (0), to few symptoms to 35 (symptomatic), administered at baseline, which measures incomplete bladder emptying, frequency, urgency, straining, and nocturia.
Baseline Patient Perception of Urgency Score (PPUS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.5  (0.85) 
[1] PPUS is in questionnaire format with a max score of 4. Subject have a single rating, low score (none) to 4 (symptoms).
Baseline Perception of Bladder Condition (PBC) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.5  (0.85) 
[1] Perception of bladder control measured in questionnaire format with single max rating up to 6, comparing baseline. Low score (none) to 6 (symptoms).
Baseline International Consultation on Incontinence Mod. Questions-Male Lower Urinary Tract Symptoms [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 67.2  (21.04) 
[1] ICIQ MLUTS (max score = 182) quality of life questionnaire to measure baseline. Low score (none to few symptoms) to 182 (very symptomatic).
Baseline International Consultation on Incontinence Mod. Questions Lower Urinary Tract Symptoms QoL [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 122.6  (59.53) 
[1] ICIQ LUTs Quality of Life with max score = 288 from a questionnaire taken at baseline. Low score (none to few symptoms) to 288 (very symptomatic).
Baseline Urinary Nerve Growth Factor (pg/ml)/Cr (mg/dl) [1] 
[Units: Ratio]
Mean (Standard Deviation)
 34.20  (56.69) 
[1] Urinary Nerve Growth Factor (uNGF) from a biomarker in pg/ml in a ratio over urinary creatinine (u-Cr) obtained from a lab tested urinalysis in mg/dl.
Baseline Urinary Nerve Growth Factor [1] 
[Units: Pg/ml]
Mean (Standard Deviation)
 37.10  (21.24) 
[1] Urine collected for urinary nerve growth factor (u-NGF with units: pg/ml) measurement at baseline.


  Outcome Measures

1.  Primary:   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) ]

2.  Primary:   Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)   [ Time Frame: change from baseline score to Month 3 ]

3.  Secondary:   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 ]

4.  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   [ Time Frame: Change from baseline to months 1, 2 and 3 ]

5.  Secondary:   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 ]

6.  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   [ Time Frame: Change from baseline to months 1, 2 and 3 ]

7.  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   [ Time Frame: Change from baseline to months 1, 2 and 3 ]

8.  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   [ Time Frame: Change from baseline to months 1, 2 and 3 ]

9.  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   [ Time Frame: Change from baseline to months 1, 2 and 3 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Timothy Boone, MD, PhD, Principal Investigator
Organization: Houston Methodist Hosptial System
phone: 713-441-6455
e-mail: tboone3@houstonmethodist.org


Publications of Results:
Other Publications:
McVary KT. 2010 AUA Benign Prostatic Hyperplasia Clinical Guidelines. Panel Chair, AUA News 2010; 15 (3) 10 - 11.
Kaplan SA. New data on Tolterodine: Do recent findings dispel questions about treating overactive bladder in men? Eur Urology 2007; Suppl 6: 10-16.


Responsible Party: Timothy Boone, MD, PhD, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01457573     History of Changes
Other Study ID Numbers: Pro00006253
IRB# 0711-0124 ( Other Identifier: HMRI IRB )
First Submitted: October 20, 2011
First Posted: October 24, 2011
Results First Submitted: April 23, 2015
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018