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Completed

NCT Number: NCT01781117

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

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.

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Key information

Conditions

Benign Prostatic Hypertrophy With Outflow Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Detrusor Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holmium Laser Enucleation of the Prostate (HoLEP)

Procedure

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

Holmium laser enucleation system and morcellator

Device

Holmium laser enucleation and morcellation

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

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

    Time frame: 6 months after HoLEP procedure

Sponsors and collaborators

Lead sponsor

KYU-SUNG LEE

Other

Collaborators

  • Samsung Medical Center

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 31, 2013
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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