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Completed

NCT Number: NCT02072499

KTP Green Light Prostatectomy Compared With Open Prostatectomy

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).

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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–95 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Hospital

Helsinki, 00029, 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 with prostate size more than 100cc

Exclusion criteria

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

Treatment and study plan

KTP Green Light Prostatectomy

Procedure

green light

Device

Open prostatectomy

Procedure

Primary outcomes

  1. IPSS (International Prostate Symptom Score)

    Time frame: 12 months

    symptom score

Secondary outcomes

  1. DAN-PSS (Danish Prostate Symptom Score)

    Time frame: 0, 3, 6 and 12 months

    symptom score

  2. Maximum flow rate (Qmax)

    Time frame: 0, 3, 6 and 12 months

  3. Residual urine

    Time frame: 0, 3, 6 and 12 months

  4. Length of catheterization

    Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks

  5. Length of hospital stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks

  6. Perioperative bleeding

    Time frame: Time of operation

  7. IIEF (International Index of Erectile Function questionnaire)

    Time frame: 0,12 months

  8. Prostate volume measured with TRUS (transrectal ultrasound)

    Time frame: 0, 12 moths

  9. Rate of unscheduled hospital contacts

    Time frame: 12 months

  10. IPSS (International Prostate Symptom Score)

    Time frame: 0, 3 and 6 months

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Registry information

Official study title

The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2014
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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