Benign Prostatic HyperplasiaHoLEP EARNCT04566588
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
A study testing EAR HoLEP and Classic HoLEP in people with Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- EAR HoLEP and Classic HoLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 11 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Health System
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- EAR HoLEP, Classic HoLEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAR HoLEPProcedure or surgery
early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
Classic HoLEPProcedure or surgery
classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| Early apical release holmium enucleation of the prostate | Experimental | Early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia Receives: Procedure: EAR HoLEP |
| Classic holmium enucleation of the prostate | Active comparator | Classic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia Receives: Procedure: Classic HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Twelve Months Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start25 Jun 2020
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Neff, MD, FACS, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566588
- Sponsor's protocol ID
- 145490
- Acronym
- HoLEP EAR
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes
- ClinicalTrials.gov ID
- NCT04566588
- Acronym / sponsor ID
- HoLEP EAR / 145490
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early apical release holmium enucleation of the prostate | Experimental | Procedure: EAR HoLEPEarly apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia |
| Classic holmium enucleation of the prostate | Active comparator | Procedure: Classic HoLEPClassic holmium enucleation of the prostate (HoLEP), as a surgical treatment for benign prostatic hyperplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAR HoLEPearly apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia | Procedure or surgery | Early apical release holmium enucleation of the prostate |
| Classic HoLEPclassic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia | Procedure or surgery | Classic holmium enucleation of the prostate |
Primary outcome
Post-operative Urinary Incontinence
Time frame: Twelve Months Post-operative
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAR HoLEP and Classic HoLEP in people with Benign Prostatic Hyperplasia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Urinary Incontinence (time frame: Twelve Months Post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.