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

NCT04699552 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-07

No results posted yet for this study

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.

Conditions

  • Prostate Disease
  • Surgery

Interventions

DEVICE

120W Lumenis Holmium:YAG laser 20J

120W Lumenis Holmium:YAG laser 20J

DEVICE

120W Lumenis Holmium:YAG laser 40 J

120W Lumenis Holmium:YAG laser 40J

DEVICE

120W Lumenis Holmium:YAG laser 60 J

120W Lumenis Holmium:YAG laser 60J

Sponsors & Collaborators

  • Lumenis Be Ltd.

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Marcelino Rivera, MD · IU Health Physicians

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2021-07-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04699552 on ClinicalTrials.gov