Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hypertrophy With Outflow Obstruction, Overactive Detrusor
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Holmium Laser Enucleation of the Prostate (HoLEP)
Holmium laser enucleation system and morcellator
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hypertrophy With Outflow Obstruction focused on measuring Benign prostatic obstruction (BPO), Detrusor overactivity (DO), Urinary nerve growth factor (NGF)
Eligibility 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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HoLEP group
Arm Description
Holmium Laser Enucleation of the Prostate (HoLEP)
Outcomes
Primary Outcome Measures
Difference in the baseline urinary NGF level between patients with and without detrusor overactivity at 6 months after HoLEP procedure
Secondary Outcome Measures
Difference in the IPSS (International Prostate Symptom Score) and uroflowmetry results between the patients with or without detrusor overactivity
Full Information
NCT ID
NCT01781117
First Posted
January 21, 2013
Last Updated
November 28, 2019
Sponsor
KYU-SUNG LEE
Collaborators
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01781117
Brief Title
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
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 Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
KYU-SUNG LEE
Collaborators
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy With Outflow Obstruction, Overactive Detrusor
Keywords
Benign prostatic obstruction (BPO), Detrusor overactivity (DO), Urinary nerve growth factor (NGF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HoLEP group
Arm Type
Experimental
Arm Description
Holmium Laser Enucleation of the Prostate (HoLEP)
Intervention Type
Procedure
Intervention Name(s)
Holmium Laser Enucleation of the Prostate (HoLEP)
Intervention Description
Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.
Intervention Type
Device
Intervention Name(s)
Holmium laser enucleation system and morcellator
Intervention Description
Holmium laser enucleation and morcellation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity
Time Frame
6 months after HoLEP procedure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Prognostic Value of the Urinary Nerve Growth Factor in the Patients With Benign Prostatic Hyperplasia
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