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Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate

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ClinicalTrials.gov Identifier: NCT04699552
Recruitment Status : Withdrawn (PI does not wish to move forward with the Study)
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Lumenis Ltd.
Information provided by (Responsible Party):
Marcelino Rivera, Indiana University

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.

Condition or disease Intervention/treatment Phase
Prostate Disease Surgery Device: 120W Lumenis Holmium:YAG laser 20J Device: 120W Lumenis Holmium:YAG laser 40 J Device: 120W Lumenis Holmium:YAG laser 60 J Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Treating surgeons will know the randomization at the time of the operation however the postoperative data analysis and results will be performed by the research team in a blinded fashion when examining clinical outcomes and adverse events
Primary Purpose: Other
Official Title: Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Arm Intervention/treatment
Experimental: 2J 20 Hz
The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 20Hz
Device: 120W Lumenis Holmium:YAG laser 20J
120W Lumenis Holmium:YAG laser 20J

Experimental: 2J 40 Hz
The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 40Hz
Device: 120W Lumenis Holmium:YAG laser 40 J
120W Lumenis Holmium:YAG laser 40J

Experimental: 2J 60 Hz
The power settings of 2J of energy will be consistent between the three treatment arms. The frequency will be 60Hz
Device: 120W Lumenis Holmium:YAG laser 60 J
120W Lumenis Holmium:YAG laser 60J




Primary Outcome Measures :
  1. Rate of patient reported postoperative UUI [ Time Frame: 1 month ]
    Rate of patient reported postoperative UUI


Secondary Outcome Measures :
  1. AE reported via Clavien-Dindo classification [ Time Frame: 24 hours ]
    AE reported via Clavien-Dindo classification

  2. Time from HoLEP to postoperative dysuria resolution [ Time Frame: 90 days ]
    Time from HoLEP to postoperative dysuria resolution

  3. Time from HoLEP to postoperative urgency resolution [ Time Frame: 90 days ]
    Time from HoLEP to postoperative urgency resolution

  4. Enucleation/Operative time [ Time Frame: 24 hours ]
    Enucleation/Operative time

  5. Total laser energy used [ Time Frame: 24 hours ]
    Total laser energy used

  6. Perioperative change in hemoglobin [ Time Frame: 6 months ]
    Perioperative change in hemoglobin

  7. Laser repair/maintenance rates [ Time Frame: 1 year ]
    Laser repair/maintenance rates

  8. New postoperative urgency incontinence rates at 1month, 3months and 6months. [ Time Frame: 6 months ]
    New postoperative urgency incontinence rates at 1month, 3months and 6months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT04699552


Locations
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United States, Indiana
IU Methodist Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Lumenis Ltd.
Investigators
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Principal Investigator: Marcelino Rivera, MD IU Health Physicians
Publications:

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Responsible Party: Marcelino Rivera, Assistant Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT04699552    
Other Study ID Numbers: 2010195334
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Marcelino Rivera, Indiana University:
Holmium Laser Enucleation
Prostate
Additional relevant MeSH terms:
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Prostatic Diseases