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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)

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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

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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

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* 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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