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Ultrasound-Guided Photoselective Vaporization of the Prostate

NCT02346500 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-09-18

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Misop Han, M.D., M.S. · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-11-26
Completion
2016-11-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02346500 on ClinicalTrials.gov