Ultrasound-Guided Photoselective Vaporization of the Prostate
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|ClinicalTrials.gov Identifier: NCT02346500|
Recruitment Status : Recruiting
First Posted : January 27, 2015
Last Update Posted : August 11, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- Recording patient-completed questionnaires (International Prostate Symptom Score (IPSS). [ Time Frame: Measurements will be recorded 3 months after the PVP procedure. ]
- Measurement of complications from the procedure including rectal injury. [ Time Frame: Measurements will be recorded during the PVP procedure. ]
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
|Contact: Misop Han, M.D., M.S.||email@example.com|
|Contact: Marilyn Agro, B.S.||firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Misop Han, M.D., M.S. 410-614-9442 email@example.com|
|Principal Investigator: Misop Han, M.D., M.S.|
|Principal Investigator:||Misop Han, M.D., M.S.||Johns Hopkins University|