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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06282731
Other study ID # ECKIRB1020407
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 31, 2013
Est. completion date April 27, 2017

Study information

Verified date February 2024
Source En Chu Kong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date April 27, 2017
Est. primary completion date September 1, 2016
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 80 Years
Eligibility 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 Design


Intervention

Drug:
Silodosin
Indications:Benign prostate hyperplasia

Locations

Country Name City State
Taiwan En Chu Kong Hospital New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
En Chu Kong Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (51)

Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90. — View Citation

Abrams PH. Detrusor instability and bladder outlet obstruction. Neurourol Urodyn. 1985;4:317-324.

Apostolidis A, Dasgupta P, Fowler CJ. Proposed mechanism for the efficacy of injected botulinum toxin in the treatment of human detrusor overactivity. Eur Urol. 2006 Apr;49(4):644-50. doi: 10.1016/j.eururo.2005.12.010. Epub 2006 Jan 4. — View Citation

Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54. — View Citation

Birder LA, Wolf-Johnston A, Griffiths D, Resnick NM. Role of urothelial nerve growth factor in human bladder function. Neurourol Urodyn. 2007;26(3):405-9. doi: 10.1002/nau.20372. — View Citation

Cheng CL, Liu JC, Chang SY, Ma CP, de Groat WC. Effect of capsaicin on the micturition reflex in normal and chronic spinal cord-injured cats. Am J Physiol. 1999 Sep;277(3):R786-94. doi: 10.1152/ajpregu.1999.277.3.R786. — View Citation

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. — View Citation

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. — View Citation

Digesu GA, Khullar V, Cardozo L, Salvatore S. Overactive bladder symptoms: do we need urodynamics? Neurourol Urodyn. 2003;22(2):105-8. doi: 10.1002/nau.10099. Erratum In: Neurourol Urodyn. 2003;22(4):356. — View Citation

Doo CK, Hong B, Chung BJ, Kim JY, Jung HC, Lee KS, Choo MS. Five-year outcomes of the tension-free vaginal tape procedure for treatment of female stress urinary incontinence. Eur Urol. 2006 Aug;50(2):333-8. doi: 10.1016/j.eururo.2006.04.007. Epub 2006 May 2. — View Citation

Duckett JR, Basu M. The predictive value of preoperative pressure-flow studies in the resolution of detrusor overactivity and overactive bladder after tension-free vaginal tape insertion. BJU Int. 2007 Jun;99(6):1439-42. doi: 10.1111/j.1464-410X.2007.06842.x. Epub 2007 Apr 5. — View Citation

Dupont MC, Spitsbergen JM, Kim KB, Tuttle JB, Steers WD. Histological and neurotrophic changes triggered by varying models of bladder inflammation. J Urol. 2001 Sep;166(3):1111-8. — View Citation

Giannantoni A, Di Stasi SM, Nardicchi V, Zucchi A, Macchioni L, Bini V, Goracci G, Porena M. Botulinum-A toxin injections into the detrusor muscle decrease nerve growth factor bladder tissue levels in patients with neurogenic detrusor overactivity. J Urol. 2006 Jun;175(6):2341-4. doi: 10.1016/S0022-5347(06)00258-8. — View Citation

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. — View Citation

Hyman MJ, Groutz A, Blaivas JG. Detrusor instability in men: correlation of lower urinary tract symptoms with urodynamic findings. J Urol. 2001 Aug;166(2):550-2; discussion 553. doi: 10.1016/s0022-5347(05)65982-4. — View Citation

Kim JC, Park EY, Seo SI, Park YH, Hwang TK. Nerve growth factor and prostaglandins in the urine of female patients with overactive bladder. J Urol. 2006 May;175(5):1773-6; discussion 1776. doi: 10.1016/S0022-5347(05)00992-4. — View Citation

Kuo HC. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology. 2005 Jul;66(1):94-8. doi: 10.1016/j.urology.2005.02.002. — View Citation

Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007. — View Citation

Lamb K, Gebhart GF, Bielefeldt K. Increased nerve growth factor expression triggers bladder overactivity. J Pain. 2004 Apr;5(3):150-6. doi: 10.1016/j.jpain.2004.01.001. — View Citation

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. — View Citation

Liu HT, Chancellor MB, Kuo HC. Urinary nerve growth factor level could be a biomarker in the differential diagnosis of mixed urinary incontinence in women. BJU Int. 2008 Nov;102(10):1440-4. doi: 10.1111/j.1464-410X.2008.07757.x. Epub 2008 May 16. — View Citation

Liu HT, Chancellor MB, Kuo HC. Urinary nerve growth factor levels are elevated in patients with detrusor overactivity and decreased in responders to detrusor botulinum toxin-A injection. Eur Urol. 2009 Oct;56(4):700-6. doi: 10.1016/j.eururo.2008.04.037. Epub 2008 Apr 30. — View Citation

Liu HT, Kuo HC. Intravesical botulinum toxin A injections plus hydrodistension can reduce nerve growth factor production and control bladder pain in interstitial cystitis. Urology. 2007 Sep;70(3):463-8. doi: 10.1016/j.urology.2007.04.038. — View Citation

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. — View Citation

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. — View Citation

Lommatzsch M, Braun A, Mannsfeldt A, Botchkarev VA, Botchkareva NV, Paus R, Fischer A, Lewin GR, Renz H. Abundant production of brain-derived neurotrophic factor by adult visceral epithelia. Implications for paracrine and target-derived Neurotrophic functions. Am J Pathol. 1999 Oct;155(4):1183-93. doi: 10.1016/S0002-9440(10)65221-2. — View Citation

Lowe EM, Anand P, Terenghi G, Williams-Chestnut RE, Sinicropi DV, Osborne JL. Increased nerve growth factor levels in the urinary bladder of women with idiopathic sensory urgency and interstitial cystitis. Br J Urol. 1997 Apr;79(4):572-7. doi: 10.1046/j.1464-410x.1997.00097.x. — View Citation

Nitti VW, Kim Y, Combs AJ. Voiding dysfunction following transurethral resection of the prostate: symptoms and urodynamic findings. J Urol. 1997 Feb;157(2):600-3. — View Citation

Nixon A, Colman S, Sabounjian L, Sandage B, Schwiderski UE, Staskin DR, Zinner N. A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials. J Urol. 2005 Aug;174(2):604-7. doi: 10.1097/01.ju.0000165461.38088.7b. — View Citation

Okragly AJ, Niles AL, Saban R, Schmidt D, Hoffman RL, Warner TF, Moon TD, Uehling DT, Haak-Frendscho M. Elevated tryptase, nerve growth factor, neurotrophin-3 and glial cell line-derived neurotrophic factor levels in the urine of interstitial cystitis and bladder cancer patients. J Urol. 1999 Feb;161(2):438-41; discussion 441-2. Erratum In: J Urol 1999 Jun;161(6):1915. — View Citation

Patel AK, Patterson JM, Chapple CR. Botulinum toxin injections for neurogenic and idiopathic detrusor overactivity: A critical analysis of results. Eur Urol. 2006 Oct;50(4):684-709; discussion 709-10. doi: 10.1016/j.eururo.2006.07.022. Epub 2006 Aug 4. — View Citation

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. — View Citation

Reitz A, Stohrer M, Kramer G, Del Popolo G, Chartier-Kastler E, Pannek J, Burgdorfer H, Gocking K, Madersbacher H, Schumacher S, Richter R, von Tobel J, Schurch B. European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol. 2004 Apr;45(4):510-5. doi: 10.1016/j.eururo.2003.12.004. — View Citation

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. — View Citation

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. — View Citation

Segal JL, Vassallo B, Kleeman S, Silva WA, Karram MM. Prevalence of persistent and de novo overactive bladder symptoms after the tension-free vaginal tape. Obstet Gynecol. 2004 Dec;104(6):1263-9. doi: 10.1097/01.AOG.0000147596.44421.72. — View Citation

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. — View Citation

Seki S, Sasaki K, Igawa Y, et al. Detrusor overactivity induced by increased levels of nerve growth factor in bladder afferent pathways in rats. Neurourol Urodyn. 2003;22:375-377.

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. — View Citation

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. — View Citation

Steers WD, Tuttle JB. Mechanisms of Disease: the role of nerve growth factor in the pathophysiology of bladder disorders. Nat Clin Pract Urol. 2006 Feb;3(2):101-10. doi: 10.1038/ncpuro0408. — View Citation

Steers WD. Pathophysiology of overactive bladder and urge urinary incontinence. Rev Urol. 2002;4 Suppl 4(Suppl 4):S7-S18. — View Citation

Tuttle JB, Steers WD, Albo M, Nataluk E. Neural input regulates tissue NGF and growth of the adult rat urinary bladder. J Auton Nerv Syst. 1994 Oct;49(2):147-58. doi: 10.1016/0165-1838(94)90134-1. — View Citation

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. — View Citation

Vizzard MA. Neurochemical plasticity and the role of neurotrophic factors in bladder reflex pathways after spinal cord injury. Prog Brain Res. 2006;152:97-115. doi: 10.1016/S0079-6123(05)52007-7. — View Citation

Weaver LC, Marsh DR, Gris D, Brown A, Dekaban GA. Autonomic dysreflexia after spinal cord injury: central mechanisms and strategies for prevention. Prog Brain Res. 2006;152:245-63. doi: 10.1016/S0079-6123(05)52016-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yoshimura N. Bladder afferent pathway and spinal cord injury: possible mechanisms inducing hyperreflexia of the urinary bladder. Prog Neurobiol. 1999 Apr;57(6):583-606. doi: 10.1016/s0301-0082(98)00070-7. — View Citation

Zvara P, Vizzard MA. Exogenous overexpression of nerve growth factor in the urinary bladder produces bladder overactivity and altered micturition circuitry in the lumbosacral spinal cord. BMC Physiol. 2007 Aug 28;7:9. doi: 10.1186/1472-6793-7-9. — View Citation

* Note: There are 51 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Urine growth factors level Check Urine growth factors level after si xmonth Six months after medical treatment
Primary Urine growth factors level Check Urine growth factors level after one month One month after medical treatment
Secondary Urine growth factors level Check Urine growth factors level afterthree month Three months after medical treatment
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