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HoLEP (50W) vs. HoLEP (100W) for Treatment of BPH

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ClinicalTrials.gov Identifier: NCT02737241
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

Brief Summary:

HoLEP (Holmium laser enucleation of the prostate) entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma.

The investigators are going to compare safety and efficacy of low power; LP-HoLEP vs. high power; HP-HoLEP in treatment of infra-vesical obstruction secondary to BPH (Benign prostate Hyperplasia).


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Procedure: Low power Holmium laser enucleation of the prostate Procedure: High power Holmium laser enucleation of the prostate Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Low Power (50W) Holmium Laser Enucleation of the Prostate (HoLEP) Versus High Power (100W) HoLEP
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium

Arm Intervention/treatment
Active Comparator: LP-HoLEP
Low power Holmium laser enucleation of the prostate
Procedure: Low power Holmium laser enucleation of the prostate
HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 50W holmium laser energy.

Active Comparator: HP-HoLEP
High power Holmium laser enucleation of the prostate
Procedure: High power Holmium laser enucleation of the prostate
HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 100W holmium laser energy.




Primary Outcome Measures :
  1. Operative time (minutes) [ Time Frame: one day ]
    Which is the time from insertion of the resectoscope till the time of catheterization

  2. Operative efficacy (gm/minute) [ Time Frame: one day ]
    Which is the number or grams of the resected prostate tissue weight divided by operative time

  3. Enucleation efficacy (gm/minute) [ Time Frame: one day ]
    Which is the number of grams of the resected prostate tissue divided by enucleation time


Secondary Outcome Measures :
  1. dysuria score [ Time Frame: 4 weeks ]
    Dysuria visual analogue scale will be used to assess postoperative dysuria at first postoperative visit

  2. Maximum urine flow rate (ml/sec) [ Time Frame: 3 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients' age ≥50 years
  2. ASA (American society of anesthesiologists) score ≤3.
  3. TRUS (transrectal ultrasound) estimated weight ≥40 grams.

Exclusion Criteria:

Patients who have any of the following were excluded:

  1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
  2. Active urinary tract infection.
  3. Presence of bladder cancer (within the last 2 years).
  4. Prostate cancer patients.
  5. Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
  6. Previous prostate surgery

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): NCT02737241


Locations
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Egypt
Urology and nephrology center
Mansoura, DK, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed M Elshal, MD Mansoura University

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Responsible Party: Ahmed Elshal, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02737241     History of Changes
Other Study ID Numbers: Mans 26-11-2015
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ahmed Elshal, Mansoura University:
Prostate
Laser
Enucleation
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male