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

NCT ID: NCT01781117

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-01-31

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.

Conditions

Benign Prostatic Hypertrophy With Outflow Obstruction; Overactive Detrusor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HoLEP group

Holmium Laser Enucleation of the Prostate (HoLEP)

Group Type: EXPERIMENTAL

Holmium Laser Enucleation of the Prostate (HoLEP)

Intervention Type: PROCEDURE

Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.

Holmium laser enucleation system and morcellator

Intervention Type: DEVICE

Holmium laser enucleation and morcellation

Interventions

Holmium Laser Enucleation of the Prostate (HoLEP)

Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.

Intervention Type: PROCEDURE

Holmium laser enucleation system and morcellator

Holmium laser enucleation and morcellation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: collaborator

KYU-SUNG LEE

OTHER

Sponsor Role: lead

Responsible Party

KYU-SUNG LEE

Professor, M.D, Ph.D

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kyu-Sung Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2012-11-013

Identifier Type: -

Identifier Source: org_study_id