Clinical Trial: A Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatme

Brief Summary: The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to TURP.

Detailed Summary:
Sponsor: American Medical Systems

Current Primary Outcome: BPH symptoms compared to TURP symptoms a 6 months post procedure [ Time Frame: 6 months ]

Original Primary Outcome: BPH symptoms versus TURP symptoms [ Time Frame: 6 months ]

Current Secondary Outcome:

• To compare the functional status of PVP and TURP via maximum urinary flow rate (Qmax) [ Time Frame: 6 months ]
  Maximum urinary flow rate (Qmax) measured at baseline and a the 6-month follow-up visits
• To compare the complication-free rate of PVP and TURP [ Time Frame: 6 months ]

  A that is subject free of device and procedure-related complications. A complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria:

  • Required a prolonged or secondary hospitalization
  • Required surgical or invasive intervention (eg, breaking of the skin) and excuding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia
  • Perforation of tissue or a physiologic structure
• To compare prostate volume post treatment for PVP and TURP [ Time Frame: 6 months ]
  Prostate volume (vis TRUS) taken at baseline and 6 month follow-up visit.
• To compare immediate post treatment outcomes of PVP and TURP [ Time Frame: 3 weeks ]
  SF-36 Acute form collected at 3-week visit (2 composite score and 6 subscores). Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
• To compare health status of PVP and TURP [ Time Frame: 2 years ]
  The IPSS, BII, OABq, SF-36 Acute and EQ-5D instruments will be scored per instructions for each instrument as collected at baseline and follow-up visit case report forms.
• To compare tolerability of PVP and TURP [ Time Frame: 2 Years ]
  The IIEF and ICIQ-SF instruments will be scored per instructions for each instrument as collected at baseline and the follow-up visit case report forms.
• To compare subject satisfaction of PVP and TURP [ Time Frame: 2 Years ]
  Subject responses to satisfaction with treatment as collected on follow-up visits.
• To compare rate of retreatment of PVP and TURP [ Time Frame: 2 Years ]
  Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required

Original Secondary Outcome:

• To compare the complication-free rate between PVP and TURP [ Time Frame: 2 years ]

  A subject that is free of device and procedure-related complications. A complication is defined as a device or procedure-related related adverse event meeting at least 1 of the following criteria:

  • required prolonged or secondary hospitalization
  • required surgical or invasive intervention (eg, breaking of skin) and excluding:
  • urinary catheterization for transient retention lasting less than 7 days
  • IV medications related to anesthesia
  • perforation of tissue or physiologic structure
• To compare prostate volume post treatment for PVP and TURP [ Time Frame: 6 months ]
  Prostate volume (via TRUS or abdominal ultrasonography) as reported on the case report forms at baseline and 6-month follow-up visit
• To compare functional status of PVP and TURP via maximum urinary flow rate (Qmax) [ Time Frame: 2 years ]
  Maximum urinary flow rate (aka Qmax, measured in ml/s) at baseline, 3, 6, 12, and 24-month follow-up visits. The proportion of subjects with a Qmax of 15ml/s or greater at 3, 6, 12, and 24-month follow-up visits. A measure of 15ml/s or greater is indicative of non-obstructed urinary flow.
• To compare immediate post treatment outcomes of PVP and TURP [ Time Frame: 3 weeks ]
  SF-36 Acute form collected at 3-week visit (2 composite score and 6 subscores). Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
• To compare health status of PVP and TURP [ Time Frame: 2 years ]
  The IPSS, BII, OABq, SF-36 Acute and EQ-5D instruments will be scored per instructions for each instrument as collected at baseline and follow-up visit case report forms. For each instrument score/subscore, descriptive statistics including mean, standard deviation, median and range will summarize values for baseline and follow-up visits. Testing for differences between the PVP and TURP arms will be performed using Student t-tests or Wilcoxon Rank Sum Test when appropriate.
• To compare tolerability of PVP and TURP [ Time Frame: 2 Years ]
  The IIEF and ICIQ-SF instruments will be scored per instructions for each instrument as collected at baseline and the follow-up visit case report forms. For each instrument score/subscore, descriptive statistics including mean, standard deviation, median and range will summarize values for baseline, 6, 12, and 24-month visits. Testing for differences between the PVP and TURP arm will be performed using Student t-tests
• To compare subject satisfaction of PVP and TURP [ Time Frame: 2 Years ]
  Subject responses to satisfaction with treatment as collected on follow-up visits. Descriptive statistics including frequency and percentages will be calculated. Proportions may be compared between PVP and TURP arms using Chi-square test with continuity correction.
• To compare rate of retreatment of PVP and TURP [ Time Frame: 2 Years ]
  Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required

Dates:
Date Received: October 8, 2010
Date Started: April 2011
Date Completion: January 2015
Last Updated: October 29, 2014
Last Verified: October 2012