ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-Guided Photoselective Vaporization of the Prostate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02346500
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Misop Han, Johns Hopkins University

Brief 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.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Transrectal Ultrasound Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Photoselective Vaporization of the Prostate
Study Start Date : December 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transrectal ultrasound
TRUS and TRUS-Robot will be used during PVP
Device: Transrectal Ultrasound
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.



Primary Outcome Measures :
  1. Measurement of prostate volume. [ Time Frame: During the study procedure, after the TRUS probe is in position for imaging of the prostate. ]
    Prostate volume will be measured before (Set I, initial: 3 min) and after (Set F, final: 3 min) the PVP.

  2. Measurement of the prostate cavity. [ Time Frame: At the end of the PVP procedure. ]
    Measurement will be estimated from the 3-D ultrasound Set F.

  3. Recording patient-completed questionnaires (International Prostate Symptom Score (IPSS). [ Time Frame: Measurements will be recorded 3 months after the PVP procedure. ]

Secondary Outcome Measures :
  1. Measurement of complications from the procedure including rectal injury. [ Time Frame: Measurements will be recorded during the PVP procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients between the ages of 40 and 85
  • patients with BPH
  • patients scheduled for PVP

Exclusion Criteria:

  • patients with known prostate cancer
  • patients with bleeding problems
  • patients with previous rectal surgery
  • patients with anal stenosis
  • patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk
  • patients with previous pelvic irradiation
  • patients with penile implants
  • patients with artificial urinary or rectal sphincters
  • patients who are unwilling or unable to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346500


Contacts
Contact: Misop Han, M.D., M.S. 410-614-9442 mhan1@jhmi.edu
Contact: Marilyn Agro, B.S. 410-502-5983 magro1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Misop Han, M.D., M.S.    410-614-9442    mhan1@jhmi.edu   
Principal Investigator: Misop Han, M.D., M.S.         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University

Responsible Party: Misop Han, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02346500     History of Changes
Other Study ID Numbers: NA_00052503
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Misop Han, Johns Hopkins University:
Benign Prostatic Hyperplasia
Lower urinary tract symptoms
Photoselective laser vaporization of the prostate
Transrectal Ultrasound

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male