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Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia

This study is not yet open for participant recruitment.
Verified January 2013 by Samsung Medical Center
Sponsor:
Collaborator:
Samsung Medical Center
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01781117
First received: January 21, 2013
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). Levels of the urinary nerve growth factor (NGF), produced by bladder urothelium and smooth muscle, are increased in the patients with overactive bladder (OAB), and decreased after the OAB symptoms were improved. Also, urinary NGF levels are increased in patients with benign prostatic obstruction (BPO), but the changes of the NGF levels after relief of the BPO by the medical or surgical treatment have not been fully investigated. If the elevated urinary NGF levels are reduced after successful surgical treatment of BPO, measurement of urinary NGF could be a useful objective tool to assess the therapeutic outcomes of the operation.

The aims of this study are to measure the urinary NGF levels in patients with BPO and to compare the results between the patients with detrusor overactivity (DO) and without detrusor overactivity (Non-DO), average 2 weeks before Holmium Laser Enucleation of the Prostate (HoLEP) procedure. After HoLEP, urinary NGF levels are rechecked at the periods of postoperative 3 months and 6 months, and compare changes between the two groups.


Condition Intervention
Benign Prostatic Hypertrophy With Outflow Obstruction
Overactive Detrusor
 Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
Device: Holmium laser enucleation system and morcellator

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prognostic Value of the Urinary Nerve Growth Factor (NGF) in the Patients With Benign Prostatic Hyperplasia (BPH) Who Undergo Holmium Laser Enucleation of the Prostate (HoLEP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Difference in the baseline urinary NGF level between patients with and without detrusor overactivity at 6 months after HoLEP procedure [ Time Frame: 6 months after HoLEP procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the IPSS (International Prostate Symptom Score) and uroflowmetry results between the patients with or without detrusor overactivity [ Time Frame: 6 months after HoLEP procedure ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity [ Time Frame: 6 months after HoLEP procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HoLEP group
Holmium Laser Enucleation of the Prostate (HoLEP)
 Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.
Device: Holmium laser enucleation system and morcellator
Holmium laser enucleation and morcellation

Detailed Description:
  • Investigators are going to enroll age-matched control group and measure the urinary NGF levels as a baseline value (30 males).
  • Investigators are going to enroll BPO patients group (DO group 50 and Non-DO group 50 patients).
  • Administration of the anti-cholinergic agents was reported to decrease urinary NGF levels. Investigators are going to try to avoid the effect of anti-muscarinic drugs.
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male aged 50 yrs or greater
  • International prostatic symptom score >= 12
  • Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
  • Ability and willingness to correctly complete the micturition diary and questionnaire
  • Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

  • Patients with urologic malignancies such as prostate cancer and bladder cancer
  • Patients underwent urethral, prostate surgery
  • Patients with urethral stricture or bladder diverticulum or bladder neck contracture
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781117

Contacts
Contact: Kyu-Sung Lee, M.D., Ph.D. 82-2-3410-3554 keleedr@skku.edu
Contact: Jeongyun Jeong, M.D., Ph.D. 82-2-3410-1404 jjyuro@hanmail.net

Locations
Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, M.D., Ph.D.     82-2-3410-3554     ksleedr@skku.edu    
Contact: Jeongyun Jeong, M.D., Ph.D.     82-2-3410-1404     jjyuro@hanmail.net    
Sub-Investigator: Jeongyun Jeong, M.D., Ph.D.            
Sub-Investigator: Bong-Hee Lim, BA            
Sponsors and Collaborators
KYU-SUNG LEE
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, M.D., Ph.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Professor, M.D, Ph.D, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01781117     History of Changes
Other Study ID Numbers: 2012-11-013
Study First Received: January 21, 2013
Last Updated: January 29, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Benign prostatic obstruction (BPO)
Detrusor overactivity (DO)
Urinary nerve growth factor (NGF)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Urinary Bladder, Overactive
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
 Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013