The Changes of Urine Growth Factors Level

The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia After Medical Treatment

The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Drug: Silodosin

Detailed Description

The prevalence of benign prostate hyperplasia, like medical illness such as hypertension, diabetes mellitus and stroke, increase by age. Benign prostate hyperplasia will cause bothersome lower urinary tract symptoms in the middle and aged male. Previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment.

Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder. As a result, investigator will investigate the changes of these growth factors level in patients with benign prostate hyperplasia before and after three and six-months medical treatment. In addition, investigator can understand whether overactive bladder will have effects on successful medical treatment in patients with benign prostate hyperplasia.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23702
    • En Chu Kong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• men with age 50~80 years old
• IPSS>12
• maximal flowrate 5~15ml/sec
• prostate size>20ml
• urine amount>150ml
• patient/family can sigh the inform concent

Exclusion Criteria:

• prostate cancer or suspected prostate cancer(PSA>4ng/ml)
• history of prostate surgery
• free of active urinary tract infection in past 6 months
• patient with any other serious disease considered by investigator not in the condition to enter trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: urine growth factor; Previous studies have showed that overactive bladder syndrome (urge, frequency, nocturia or urinary incontinence) has been considered as an important factor to predict successful treatment. Urine nerve growth factor level, brain-derived neurotrophic factor and endothelium vascular growth factor have been proved as a simple and noninvasive biomarker for diagnosing overactive bladder.

Drug: Silodosin; Indications:Benign prostate hyperplasia; Other Names: Finasteride; Dutasteride; Tamsulosin HCl; Doxazosin (methanesulfonate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine growth factors level	Check Urine growth factors level after one month	One month after medical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine growth factors level	Check Urine growth factors level afterthree month	Three months after medical treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine growth factors level	Check Urine growth factors level after si xmonth	Six months after medical treatment

Collaborators and Investigators

• Sponsor: En Chu Kong Hospital
• Investigators: Principal Investigator: Cheng Cheng Wang, M.D Ph.D, Department of urology,En Chu Nong Hospital

Publications and helpful links

General Publications

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• Popat R, Apostolidis A, Kalsi V, Gonzales G, Fowler CJ, Dasgupta P. A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol. 2005 Sep;174(3):984-9. doi: 10.1097/01.ju.0000169480.43557.31.
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• Vizzard MA. Changes in urinary bladder neurotrophic factor mRNA and NGF protein following urinary bladder dysfunction. Exp Neurol. 2000 Jan;161(1):273-84. doi: 10.1006/exnr.1999.7254.
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• Yoshimura N, Bennett NE, Hayashi Y, Ogawa T, Nishizawa O, Chancellor MB, de Groat WC, Seki S. Bladder overactivity and hyperexcitability of bladder afferent neurons after intrathecal delivery of nerve growth factor in rats. J Neurosci. 2006 Oct 18;26(42):10847-55. doi: 10.1523/JNEUROSCI.3023-06.2006.
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• Liu HT, Kuo HC. Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology. 2008 Jul;72(1):104-8; discussion 108. doi: 10.1016/j.urology.2008.01.069. Epub 2008 Apr 8.
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• 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.
• 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.
• Coyne KS, Zhou Z, Thompson C, Versi E. The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int. 2003 Nov;92(7):731-5. doi: 10.1046/j.1464-410x.2003.04463.x.
• Werner M, Schmid DM, Schussler B. Efficacy of botulinum-A toxin in the treatment of detrusor overactivity incontinence: a prospective nonrandomized study. Am J Obstet Gynecol. 2005 May;192(5):1735-40. doi: 10.1016/j.ajog.2004.11.052.
• Schmid DM, Sauermann P, Werner M, Schuessler B, Blick N, Muentener M, Strebel RT, Perucchini D, Scheiner D, Schaer G, John H, Reitz A, Hauri D, Schurch B. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. J Urol. 2006 Jul;176(1):177-85. doi: 10.1016/S0022-5347(06)00590-8.
• De Wachter S, Wyndaele JJ. Frequency-volume charts: a tool to evaluate bladder sensation. Neurourol Urodyn. 2003;22(7):638-42. doi: 10.1002/nau.10160.
• Steers WD, Kolbeck S, Creedon D, Tuttle JB. Nerve growth factor in the urinary bladder of the adult regulates neuronal form and function. J Clin Invest. 1991 Nov;88(5):1709-15. doi: 10.1172/JCI115488.
• 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. doi: 10.1002/nau.20519.
• Romanzi LJ, Groutz A, Heritz DM, Blaivas JG. Involuntary detrusor contractions: correlation of urodynamic data to clinical categories. Neurourol Urodyn. 2001;20(3):249-57. doi: 10.1002/nau.1002.
• Hashim H, Abrams P. Is the bladder a reliable witness for predicting detrusor overactivity? J Urol. 2006 Jan;175(1):191-4; discussion 194-5. doi: 10.1016/S0022-5347(05)00067-4.
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• Seki S, Sasaki K, Fraser MO, Igawa Y, Nishizawa O, Chancellor MB, de Groat WC, Yoshimura N. Immunoneutralization of nerve growth factor in lumbosacral spinal cord reduces bladder hyperreflexia in spinal cord injured rats. J Urol. 2002 Nov;168(5):2269-74. doi: 10.1016/S0022-5347(05)64369-8.
• Seki S, Sasaki K, Igawa Y, Nishizawa O, Chancellor MB, De Groat WC, Yoshimura N. Suppression of detrusor-sphincter dyssynergia by immunoneutralization of nerve growth factor in lumbosacral spinal cord in spinal cord injured rats. J Urol. 2004 Jan;171(1):478-82. doi: 10.1097/01.ju.0000088340.26588.74.
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Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): April 27, 2017

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Benigh Prostate Hyperplasia(BPH); Urine Growth Factors
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Tamsulosin; Dutasteride; Doxazosin; Silodosin; Finasteride
• Other Study ID Numbers: ECKIRB1020407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No