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

NCT01781117 | Completed

• 1 other identifier: 2012-11-013
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hypertrophy With Outflow Obstruction; Overactive Detrusor

Keywords

Benign prostatic obstruction (BPO); Detrusor overactivity (DO); Urinary nerve growth factor (NGF)

Outcome Measures

Primary Outcomes (1)

• Difference in the baseline urinary NGF level between patients with and without detrusor overactivity at 6 months after HoLEP procedure

  6 months after HoLEP procedure

Secondary Outcomes (1)

• Difference in the IPSS (International Prostate Symptom Score) and uroflowmetry results between the patients with or without detrusor overactivity

  6 months after HoLEP procedure

Other Outcomes (1)

• Difference in the serum PSA (Prostate Specific Antigen) level between the patients with or without detrusor overactivity

  6 months after HoLEP procedure

Study Arms (1)

HoLEP group

EXPERIMENTAL

Holmium Laser Enucleation of the Prostate (HoLEP)

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP); Device: Holmium laser enucleation system and morcellator

Interventions

Holmium Laser Enucleation of the Prostate (HoLEP) PROCEDURE

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

HoLEP group

Holmium laser enucleation system and morcellator DEVICE

Holmium laser enucleation and morcellation

HoLEP group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KYU-SUNG LEE: lead
• Samsung Medical Center: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyu-Sung Lee, M.D., Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D, Ph.D

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 31, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

KR (1)