Ultrasound-Guided Photoselective Vaporization of the Prostate

Completed · Early Phase 1

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT02346500

Run by

Johns Hopkins University

People needed

1

Starts

2012-12-01

Expected to finish

2016-11-26

Last updated by the study team

2018-09-18

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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