Clinical trial NCT04699552: Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate
Official title: Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Disease
Surgery
Keywords: Holmium Laser Enucleation
Prostate
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Lumenis Be Ltd.
First posted: 2021-01-07
Enrollment: 0
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: The purpose of this study is to evaluate the safety and outcomes, such as postoperative dysuria (pain during urination), urgency (frequent need to urinate) and urinary incontinence (leaking urine or inability to hold urine), of 3 different HoLEP laser settings.

Detailed description: Study subjects will be identified by the clinical team or study coordinator either at the time surgery is scheduled or by review of the surgery schedule. Each subject will be screened for inclusion/exclusion criteria by reviewing the chart. If inclusion/exclusion criteria are met, the patient will be approached by a member of the research team for enrollment into the study. The patient must consent to participate by reviewing a study-specific, IRB-approved informed consent form before any study data is collected.

After informed consent has been obtained, a complete medical history including a detailed urologic history will be obtained prior to the HoLEP procedure. Standard pre-operative laboratory tests will be obtained, including a complete blood count, basic metabolic panel and urine culture.

Pre-operative, intra-operative and post-operative management of the patients included in this study will not differ from routine HoLEP treatment options described in the literature and practiced at our center. All laser settings examined are currently utilized. A complete description of the HoLEP procedure at our institution has previously been described15. Briefly, a 550um Lumenis MOSES fiber will be utilized. A 120W Holmium:YAG laser made by Lumenis will be used. Operatively, the time (minutes) for resection of the tissue will be recorded as "enucleation time". Once enucleation of the tissue has been completed, the time (in minutes) for complete removal of the enucleated tissue will be recorded as "morcellation time". Enucleated tissue can be removed by any means determined necessary by the surgeon, i.e. he/she may use the holmium laser or graspers in combination with the morcellator. Enucleation is typically performed in a stepwise fashion with an initial groove at the 5 and 7 o'clock position, followed by enucleation of the median lobe. The enucleation of the lateral lobes occurs in a bottom up approach. At times depending on patient anatomy an intraoperative decision by the treating surgeon may result in an early apical release. The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will differ from 20Hz, 40Hz and 60Hz between the three treatment arms. After enucleation, hemostasis is performed at a setting of 1J and 20 Hz with a widened pulse width for standard HoLEPs. For patients with a high median bar of bladder neck tissue, a single incision at the bladder neck is made at 6 o'clock. Total amount of laser energy utilized for the procedure will also be recorded.

Note will be made of concurrent procedures done at the time of HoLEP including: bladder calculi managed with cystolithopaxy or upper urinary tract calculi management.

Postoperative, patients will be provided with daily Twilio assessments of their postoperative dysuria, urgency and urgency urinary incontinence (as defined above) until it has resolved and remained symptom free x 3 consecutive days. Follow up Twilio assessments at 1month, 3month and 6months will be performed. Patients will concurrently follow up for standard postoperative face-to-face or virtual visit evaluations with their surgical team at 3months.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
* Able to give informed consent.
* Age 18 years or older.

Exclusion Criteria:

* Inability to give informed consent.
* Age less than 18 years.

Primary outcomes:
measure: Rate of patient reported postoperative UUI
timeFrame: 1 month
Secondary outcomes:
measure: AE reported via Clavien-Dindo classification
timeFrame: 24 hours
measure: Time from HoLEP to postoperative dysuria resolution
timeFrame: 90 days
measure: Time from HoLEP to postoperative urgency resolution
timeFrame: 90 days
measure: Enucleation/Operative time
timeFrame: 24 hours
measure: Total laser energy used
timeFrame: 24 hours
measure: Perioperative change in hemoglobin
timeFrame: 6 months
measure: Laser repair/maintenance rates
timeFrame: 1 year
measure: New postoperative urgency incontinence rates at 1month, 3months and 6months.
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Methodist Hospital
state: Indiana
Study officials:
affiliation: IU Health Physicians
name: Marcelino Rivera, MD
role: PRINCIPAL_INVESTIGATOR
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