Ultrasound-Guided Photoselective Vaporization of the Prostate

NCT02346500 | Completed Early Phase 1 DMC

• 1 other identifier: NA_00052503
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Lower urinary tract symptoms; Photoselective laser vaporization of the prostate; Transrectal Ultrasound

Outcome Measures

Primary Outcomes (3)

• Measurement of prostate volume.

  Prostate volume will be measured before (Set I, initial: 3 min) and after (Set F, final: 3 min) the PVP.

  During the study procedure, after the TRUS probe is in position for imaging of the prostate.

• Measurement of the prostate cavity.

  Measurement will be estimated from the 3-D ultrasound Set F.

  At the end of the PVP procedure.

• Recording patient-completed questionnaires (International Prostate Symptom Score (IPSS).

  Measurements will be recorded 3 months after the PVP procedure.

Secondary Outcomes (1)

• Measurement of complications from the procedure including rectal injury.

  Measurements will be recorded during the PVP procedure.

Study Arms (1)

Transrectal ultrasound

EXPERIMENTAL

TRUS and TRUS-Robot will be used during PVP

Device: Transrectal Ultrasound

Interventions

Transrectal Ultrasound DEVICE

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.

Transrectal ultrasound

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Misop Han, M.D., M.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: January 27, 2015
• Study Start: December 1, 2012
• Primary Completion: November 26, 2016
• Study Completion: November 26, 2016
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

US (1)