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Completed

NCT Number: NCT00908427

Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic BPH
  • International Score Prostate Symptom (IPSS) of 13 or greater
  • prostate volume of 30 to 100 ML
  • Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL
  • Able to give fully informed consent

Exclusion criteria

  • Subjects with histological diagnosis of prostate cancer
  • Subjects with history of chronic urinary retention
  • Subjects with urethral stricture,
  • Subjects with bladder neck contracture
  • Subjects with urinary tract infection
  • Subjects with prostate volume on TRUS of >100 mL
  • Subjects with suspected neurogenic bladder dysfunction
  • Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Treatment and study plan

photoselective vaporization prostatectomy (PVP)

Procedure

PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)

Other names: PVP

transurethral resection of the prostate

Procedure

Standard transurethral resection of the prostate using electrocautery loop

Other names: TURP

Primary outcomes

  1. The changes of bladder outlet obstruction index (BOOI)

    Time frame: 6months

Secondary outcomes

  1. The changes of Quality of Life (QoL) parameters

    Time frame: 6, 12 months

  2. The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)

    Time frame: 6, 12 months

  3. The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters

    Time frame: 6months

  4. The changes of International Prostatic Symptom Scores (IPSS)

    Time frame: 6, 12 months

  5. The changes of Schafer obstruction grade parameters

    Time frame: 6months

  6. The changes of prostate volume

    Time frame: 6, 12 months

  7. postoperative catheterization days

    Time frame: immediate postoperative period

  8. Complications

    Time frame: During all study periods

  9. The changes of the hemoglobin and the serum sodium and the serum PSA

    Time frame: immediate postoperative period

  10. The change of IIEF score

    Time frame: 6, 12 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
May 25, 2009
Registry last updated
May 25, 2009

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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