Clinical trial NCT04979143: Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
Official title: Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2021-07-28
Enrollment: 124
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization.

Detailed description: Patients will be evaluated preoperatively per standard of care in urology clinic. We will obtain American Urological Association Symptom Score (AUA-SS) and Quality of Life (QoL) assessment as well as post-void residual bladder scan (PVR), and prostate specific antigen (PSA). All of these assessments will be part of standard of care.

Based on the current coronavirus (COVID-19) pandemic and the changing health landscape with increased emphasis on telehealth, patient may be offered virtual appointments for aspects of the trial that do not require in-person evaluation or testing. These include but are not limited to inclusion/exclusion criteria evaluation, consent for trial participation, or survey completion.

Patients will be taken to the operating room per standard of care. They will be randomized to either Holmium Laser Vaporization of Prostate (HoLVP) with or without the use of Moses 2.0 technology. The surgeon and patient will both be blinded to the laser mode.

HoLVP will occur in standard fashion thereafter utilizing at 550-micron holmium Xpeeda side fire laser fiber at settings of 2 Joules, 50 Hertz. Moses 2.0 will be activated or not by operating room personnel based on patient's randomization status. Again, the surgeon and assistant will not be informed of the Moses status.

Intraoperative parameters will be recorded including total procedure time, total vaporization time, vaporization efficiency (g/min), and total energy used. Surgeons will evaluate tissue char, visibility, hemostasis, as well as select if they think Moses 2.0 was activated or not for the procedure.

Timeline for catheter removal will be per surgeon discretion with a general plan for removal in the post-anesthesia care unit with trial of void before discharge on day of surgery. If patient is discharged with a catheter in place, removal date will be determined per surgeon's discretion.

Patients will be seen in urology clinic for follow up per standard of care at 6 weeks, 3 months, and 12 months post operatively at which time we will obtain symptom questionnaires. A PVR will be obtained at 6 weeks. PSA will be measured at 3 months post operatively, to act as a surrogate marker for percentage of tissue vaporized since it can be compared to pre-operative PSA.

Outcomes from surgery will be assessed including changing in AUA-SS and QoL, and PVR. We will also evaluate for complications such as urethral stricture, bladder neck contracture, and need for re-operation.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Patients with bothersome lower urinary tract symptoms who opt for surgical management
* Prostate size 60g or less

Exclusion Criteria:

* Current use of anticoagulation or antiplatelet agent Aspirin 81 use is okay and can be continued through the study
* Bleeding diathesis
* AUA symptom score \< 9
* Current urinary retention
* Known diagnosis of prostate cancer
* Known diagnosis of neurogenic bladder

Primary outcomes:
measure: The primary outcome is vaporization efficiency, measured in g/min
timeFrame: 5 years
Secondary outcomes:
measure: Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale
timeFrame: 5 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Donald Neff
role: PRINCIPAL_INVESTIGATOR
References: