Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
|ClinicalTrials.gov Identifier: NCT01781117|
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : January 31, 2013
Last Update Posted : February 16, 2015
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 or disease||Intervention/treatment||Phase|
|Benign Prostatic Hypertrophy With Outflow Obstruction Overactive Detrusor||Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) Device: Holmium laser enucleation system and morcellator||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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
- 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 ]
- 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 ]
- Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity [ Time Frame: 6 months after HoLEP procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781117
|Contact: Kyu-Sung Lee, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: Jeongyun Jeong, M.D., Ph.D.||email@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Kyu-Sung Lee, M.D., Ph.D. 82-2-3410-3554 firstname.lastname@example.org|
|Contact: Jeongyun Jeong, M.D., Ph.D. 82-2-3410-1404 email@example.com|
|Sub-Investigator: Jeongyun Jeong, M.D., Ph.D.|
|Sub-Investigator: Bong-Hee Lim, BA|
|Principal Investigator:||Kyu-Sung Lee, M.D., Ph.D.||Samsung Medical Center|