Back to resultsEarly Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes (HoLEP EAR)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EAR HoLEP
Classic HoLEP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Patients must be 18 years of age or older
- Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
- Patients must be scheduled to undergo a holmium laser enucleation of the prostate
Exclusion Criteria:
- Patients with previous surgical management of BPH
- Patients with prostate biopsy revealing high risk prostate cancer
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
Sites / Locations
- University of Kansas Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early apical release holmium enucleation of the prostate
Classic holmium enucleation of the prostate
Arm Description
Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia
Outcomes
Primary Outcome Measures
Post-operative Urinary Incontinence
to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage
Secondary Outcome Measures
Full Information
NCT ID
NCT04566588
First Posted
September 22, 2020
Last Updated
September 22, 2020
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04566588
Brief Title
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
Acronym
HoLEP EAR
Official Title
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early apical release holmium enucleation of the prostate
Arm Type
Experimental
Arm Description
Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
Arm Title
Classic holmium enucleation of the prostate
Arm Type
Active Comparator
Arm Description
Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia
Intervention Type
Procedure
Intervention Name(s)
EAR HoLEP
Intervention Description
early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
Intervention Type
Procedure
Intervention Name(s)
Classic HoLEP
Intervention Description
classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia
Primary Outcome Measure Information:
Title
Post-operative Urinary Incontinence
Description
to determine if patients who undergo early apical release HoLEP have reduced rates of post-operative urinary incontinence compared to classic HoLEP as measured by patient report of leakage
Time Frame
Twelve Months Post-operative
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be 18 years of age or older
Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
Patients must be scheduled to undergo a holmium laser enucleation of the prostate
Exclusion Criteria:
Patients with previous surgical management of BPH
Patients with prostate biopsy revealing high risk prostate cancer
Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Dahlgren
Phone
913-574-0847
Email
adahlgren@kumc.edu
Facility Information:
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
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