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Clinical Trials/NCT04648176
NCT04648176
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Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country400 target enrollmentMarch 6, 2020
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ConditionsBenign Prostatic Hyperplasia (BPH)Lower Urinary Tract Symptoms

Overview

Phase
N/A
Intervention
Not specified
Conditions
Benign Prostatic Hyperplasia (BPH)
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
400
Locations
1
Primary Endpoint
Hemoglobin
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.

Detailed Description

In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.

Registry
clinicaltrials.gov
Start Date
March 6, 2020
End Date
June 30, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Prostatic volume between 70-200cc
  • •Acceptance to participate in the study.

Exclusion Criteria

  • •Previous urethra stricture
  • •Previous prostate surgery
  • •Neurogenic bladder
  • •Bladder tumor
  • •Neurological disease with repercussion in the lower urinary tract.
  • •Severe psychiatric illness
  • •Inability of the patient to consent

Outcomes

Primary Outcomes

Hemoglobin

Time Frame: 24 hours after the surgery

Hemoglobin change

Secondary Outcomes

  • Enucleation time(during the surgery)
  • Irrigated volume of serum(during the surgery)
  • complication rate(one month after the surgery)
  • lower urinary tract symptoms(through study completion, an average of 3 years)
  • Hemostasis time(during the surgery)
  • Morcellating time(during the surgery)
  • sexual function(through study completion, an average of 3 years)
  • urinary tract infection(one month after the surgery)
  • Surgery time(during the surgery)

Study Sites (1)

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