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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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 8, 2014
Last verified: January 2014

January 21, 2013
January 8, 2014
February 2013
February 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01781117 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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 ]
Same as current
 
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
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)

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.

  • 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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Benign Prostatic Hypertrophy With Outflow Obstruction
  • Overactive Detrusor
  • 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
Experimental: HoLEP group
Holmium Laser Enucleation of the Prostate (HoLEP)
Interventions:
  • Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)
  • Device: Holmium laser enucleation system and morcellator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Male
50 Years to 80 Years
Yes
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
Korea, Republic of
 
NCT01781117
2012-11-013
No
KYU-SUNG LEE, Samsung Medical Center
KYU-SUNG LEE
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP