Ultrasound-Guided Photoselective Vaporization of the Prostate
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Benign prostatic hyperplasia (BPH) is a major cause of lower urinary tract symptoms (LUTS)
      affecting aging men. Medical therapy for BPH includes alpha adrenergic blockers and
      5α-reductase inhibitors. In men with moderate-severe LUTS due to BPH, surgical therapy should
      be considered for 1) those who failed medical therapy and/or 2) those with refractory urinary
      retention, renal insufficiency secondary to BPH, recurrent urinary tract infections (UTI's),
      or bladder stones. The gold standard for the surgical therapy of BPH has been transurethral
      resection of the prostate (TURP). However, TURP is associated with significant comorbidities
      such as bleeding, prolonged catheterization, and absorptional hyponatremia. To minimize these
      problems associate with TURP, alternative minimally invasive treatment techniques have been
      developed. Two of the most commonly used treatment modalities include a photoselective laser
      vaporization of the prostate (GreenLight PVP) using the potassium titanyl phosphate (KTP)
      laser and holmium laser enucleation of prostate (HoLEP). The major problem in all these
      minimally invasive treatment modalities is that they are generally associated with a higher
      retreatment rate. In addition, there is no intraoperative and objective measurement, other
      than a limited, transurethral visualization of the prostatic cavity, to assess the extent of
      the vaporization or enucleation.

      We propose to use the transrectal ultrasound (TRUS) and a novel robot, the TRUS robot, to
      hold and manipulate the TRUS probe to monitor the extent of the vaporization or enucleation
      of the prostate gland intraoperatively. TRUS has been extensively used for the biopsy needle
      guidance during prostate biopsy. However, it has never been used during transurethral
      prostate procedure. The TRUS Robot has been used safely in the current clinical trial,
      NA_00027540, Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical
      Prostatectomy. We would like to study the feasibility and safety of using TRUS and the TRUS
      Robot to monitor the minimally invasive treatment of BPH, such as GreenLight PVP.
    

Detailed description: 
      In the current pilot safety and feasibility (S&F) study for ultrasound-guided PVP (UG-PVP),
      we propose to use TRUS and the TRUS-Robot to record ultrasound images during PVP in 10
      patients. The PVP procedure will be conducted as usual, without using the ultrasound for
      guiding the intervention. TRUS images of the prostate gland and the intraprostatic cavity
      formed during the PVP procedure will be recorded. These will include three dimensional (3-D)
      images acquired at the beginning and end of the operation. In addition, real-time 2-D images
      will be recorded during the case. Recorded images will then be analyzed offline to observe
      the extent of the vaporization or enucleation of the prostate gland.
    

Intervention name(s): Transrectal Ultrasound
Intervention type(s): Device
Intervention description(s): The TRUS and TRUS-Robot will be used to record ultrasound images during PVP. The PVP procedure will be conducted as usual, without using the ultrasound for guiding the intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Benign Prostatic Hyperplasia; Lower urinary tract symptoms; Photoselective laser vaporization of the prostate; Transrectal Ultrasound