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

January 5, 2021 updated by: Marcelino Rivera, Indiana University

Effect of Laser Settings on Postoperative Voiding Symptoms in Patients Undergoing Holmium Laser Enucleation of the Prostate: A Randomized Prospective Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patient reported postoperative UUI
Time Frame: 1 month
Rate of patient reported postoperative UUI
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE reported via Clavien-Dindo classification
Time Frame: 24 hours
AE reported via Clavien-Dindo classification
24 hours
Time from HoLEP to postoperative dysuria resolution
Time Frame: 90 days
Time from HoLEP to postoperative dysuria resolution
90 days
Time from HoLEP to postoperative urgency resolution
Time Frame: 90 days
Time from HoLEP to postoperative urgency resolution
90 days
Enucleation/Operative time
Time Frame: 24 hours
Enucleation/Operative time
24 hours
Total laser energy used
Time Frame: 24 hours
Total laser energy used
24 hours
Perioperative change in hemoglobin
Time Frame: 6 months
Perioperative change in hemoglobin
6 months
Laser repair/maintenance rates
Time Frame: 1 year
Laser repair/maintenance rates
1 year
New postoperative urgency incontinence rates at 1month, 3months and 6months.
Time Frame: 6 months
New postoperative urgency incontinence rates at 1month, 3months and 6months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Lumenis Be Ltd.

Investigators

  • Principal Investigator: Marcelino Rivera, MD, IU Health Physicians

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010195334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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