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Completed

NCT Number: NCT02011308

KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00350, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men undergoing surgery for BPH

Exclusion criteria

  • Previous prostate surgery
  • Carcinoma of the prostate
  • Neurogenic bladder
  • Bladder carcinoma

Treatment and study plan

Green light Laser

Device

Laser vs TURP

Transurethral Resection of the Prostate (TURP)

Device

Laser vs TURP

Primary outcomes

  1. IPSS (International Prostate Symptom Score)

    Time frame: 12 months

    symptom

Secondary outcomes

  1. DAN-PSS (Danish Prostate Symptom Score)

    Time frame: 3, 6 and 12 months

    symptom

  2. Maximum flow rate (Qmax)

    Time frame: 3, 6 and 12 months

  3. Residual urine

    Time frame: 3, 6 and 12 months

  4. Length of catheterization

    Time frame: Postoperative recovery

  5. Length of hospital stay

    Time frame: Postoperative recovery

  6. Perioperative bleeding

    Time frame: Time of operation

  7. IIEF (International Index of Erectile Function questionnaire)

    Time frame: 12 months

    Erectile Dysfunction

  8. TRUS (transrectal ultrasound)

    Time frame: 12 months

    Measurement of prostate size

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Oulu University Hospital
  • South Ostrobothnia Health Care District
  • Tampere University
  • University of Turku

Registry information

Official study title

The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2013
Registry last updated
Nov 14, 2017

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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