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Completed

NCT Number: NCT00877669

Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

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

  • 50 yrs or greater
  • International prostatic symptom score >= 12
  • Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
  • Able to give fully informed consent

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
  • Patients with histories of bacterial prostatitis within 1 year
  • seems not to be appropriate to this study by the decision of investigators because of any other reasons

Treatment and study plan

transurethral resection of the prostate

Procedure

Standard transurethral resection of the prostate using electrocautery loop

Other names: TURP

holmium laser enucleation of the prostate

Procedure

HoLEP using 100W Ho:YAG laser

Primary outcomes

  1. The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

  2. The changes of IPSS and QoL parameters

    Time frame: 1 month and 3months after operation

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

    Time frame: 2 weeks and 3 and 6 months after operation

  4. Postoperative hospital stay days and postoperative catheterization days

    Time frame: immediate postoperative period

  5. The changes of the hemoglobin and the serum sodium

    Time frame: 0 and 1 day after operation

  6. Operative time and Resected tissue weight

    Time frame: 0 day after operation

  7. The changes of ICS male questionnaire (short form) parameters

    Time frame: 3 and 6 months after operation

  8. The changes of international index of erectile function (IIEF)-15 parameters

    Time frame: 6 months after operation

  9. The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters

    Time frame: 3 and 6 months after operation

  10. The changes of voiding frequencies and urgency parameters in Frequency volume chart

    Time frame: 3 and 6 months after operation

  11. Ejaculation parameter

    Time frame: 6 months after operation

  12. Complications

    Time frame: During all study periods

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Apr 8, 2009
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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