BPH With Urinary ObstructionPhase 3NCT05620784
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
A Phase 3 study testing Furosemide in people with BPH With Urinary Obstruction and BPH, run by Northwestern University at 1 site in United States.
Trial summary
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH With Urinary Obstruction, BPH, Hematuria
- What is being tested?
- Furosemide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Aug 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males 18 -89 undergoing HoLEP
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires.
Who cannot join
- Allergy or hypersensitivity to furosemide or other loop diuretic
- Anuric patients or patients with liver failure
- Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
- Anticipated need for perineal urethrostomy at the time of HoLEP
- Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Nicholas Dean, MD, nicholas.dean@nm.org
Alyssa McDonald, alyssa.mcdonald@northwestern.edu
About this study
Official title: Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration. With increasing surgical efficiency from improvements in laser and morcellator technology, the role of intra-operative furosemide is unknown. This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide. .
Read the detailed description
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration.
This single-center randomized controlled trial is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). We currently attempt to perform HoLEP as a same-day discharge (SDD) procedure, however one of the main limiting factors in SDD is hematuria. Loop diuretics (furosemide) have been administered at the time of morcellation as a part of our HoLEP pathway to increase post-operative urinary output and reduce clinically significant gross hematuria and clot-formation. The objective of our study will be to assess if SDD rates are non-inferior in those patients who do not receive furosemide diuretics versus those that do.
Patients will be randomized 1:1 to 20mg of IV lasix versus control. Patients and the surgeon/post-operative care team (fellow, residents, and nursing team) will be blinded to the treatment allocation.
- Conditions
- BPH With Urinary Obstruction, BPH, Hematuria, Same Day Discharge
- Being tested
- Furosemide
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Lasix, Loop diuretic
20mg of IV furosemide injection during the morcellation phase of HoLEP
| Study group | Role | What they receive |
|---|---|---|
| Loop Diuretic (Furosemide) | Experimental | This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP. Receives: Drug: Furosemide |
| Control | No intervention | This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Same-day discharge
Rate of successful same-day discharge after HoLEP
Measured: 90-days
Same-day catheter removals
Rate of successful same-day catheter removals after HoLEP
Measured: 90-days
Secondary outcomes (6)
Adverse medical events (hematuria)
Rate of unplanned Emergency Department (ED) visits/clinic visits related to bleeding/admission/clot evacuation
Measured: 90-days
Adverse medical events (fluid absorption)
Rate of transurethral resection (TUR) syndrome, vision changes, seizure, hyponatremia, electrolyte abnormality
Measured: 90-days
Duration of post-operative hematuria
(days)
Measured: 90-days
Difference in operative efficiency (enucleation, morcellation, and overall)
(minutes/gram)
Measured: 90-days
Length of hospital stay
(hours)
Measured: 90-days
Overall complications
Clavien-Dindo Classification
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Mar 2023
- Primary completion6 Jun 2023
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BPH With Urinary ObstructionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
- Investigators
- Amy E Krambeck, MD, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620784
- Sponsor's protocol ID
- STU00217795
- Status last verified
- Sep 2023
- First submitted
- 11 Nov 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.
PubMed 32698710Agarwal DK, Large T, Tong Y, Stoughton CL, Damler EM, Nottingham CU, Rivera ME, Krambeck AE. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2022 Jan;8(1):228-234. doi: 10.1016/j.euf.2020.12.018. Epub 2021 Jan 4.
PubMed 33414073Kuo RL, Paterson RF, Kim SC, Siqueira TM Jr, Elhilali MM, Lingeman JE. Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update. World J Surg Oncol. 2003 Jun 6;1(1):6. doi: 10.1186/1477-7819-1-6.
PubMed 12818001Elzayat E, Habib E, Elhilali M. Holmium laser enucleation of the prostate in patients on anticoagulant therapy or with bleeding disorders. J Urol. 2006 Apr;175(4):1428-32. doi: 10.1016/S0022-5347(05)00645-2.
PubMed 16516015
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT05620784
- Acronym / sponsor ID
- STU00217795
- Conditions
- BPH With Urinary Obstruction, BPH, Hematuria, Same Day Discharge
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 17 Nov 2022 (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.
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration. With increasing surgical efficiency from improvements in laser and morcellator technology, the role of intra-operative furosemide is unknown. This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide. .
Detailed description
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration.
This single-center randomized controlled trial is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). We currently attempt to perform HoLEP as a same-day discharge (SDD) procedure, however one of the main limiting factors in SDD is hematuria. Loop diuretics (furosemide) have been administered at the time of morcellation as a part of our HoLEP pathway to increase post-operative urinary output and reduce clinically significant gross hematuria and clot-formation. The objective of our study will be to assess if SDD rates are non-inferior in those patients who do not receive furosemide diuretics versus those that do.
Patients will be randomized 1:1 to 20mg of IV lasix versus control. Patients and the surgeon/post-operative care team (fellow, residents, and nursing team) will be blinded to the treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Loop Diuretic (Furosemide) | Experimental | Drug: FurosemideThis group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP. |
| Control | No intervention | –This group of patients will not receive 20mg of IV furosemide during the morcellation phase of their HoLEP. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males 18 -89 undergoing HoLEP
- Willing to sign the Informed Consent Form
- Able to read, understand, and complete patient questionnaires.
Key exclusion criteria (5 listed)
- Allergy or hypersensitivity to furosemide or other loop diuretic
- Anuric patients or patients with liver failure
- Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
- Anticipated need for perineal urethrostomy at the time of HoLEP
- Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital
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 |
|---|---|---|
| FurosemideAlso: Lasix, Loop diuretic20mg of IV furosemide injection during the morcellation phase of HoLEP | Drug | Loop Diuretic (Furosemide) |
Primary outcome
Same-day discharge
Time frame: 90-days
Rate of successful same-day discharge after HoLEP
Same-day catheter removals
Time frame: 90-days
Rate of successful same-day catheter removals after HoLEP
6 secondary outcomes
Adverse medical events (hematuria)
Time frame: 90-days
Adverse medical events (fluid absorption)
Time frame: 90-days
Duration of post-operative hematuria
Time frame: 90-days
Difference in operative efficiency (enucleation, morcellation, and overall)
Time frame: 90-days
Length of hospital stay
Time frame: 90-days
Overall complications
Time frame: 90-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 32698710Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.
- Background: PubMed 33414073Agarwal DK, Large T, Tong Y, Stoughton CL, Damler EM, Nottingham CU, Rivera ME, Krambeck AE. Same Day Discharge is a Successful Approach for the Majority of Patients Undergoing Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2022 Jan;8(1):228-234. doi: 10.1016/j.euf.2020.12.018. Epub 2021 Jan 4.
- Background: PubMed 12818001Kuo RL, Paterson RF, Kim SC, Siqueira TM Jr, Elhilali MM, Lingeman JE. Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update. World J Surg Oncol. 2003 Jun 6;1(1):6. doi: 10.1186/1477-7819-1-6.
- Background: PubMed 16516015Elzayat E, Habib E, Elhilali M. Holmium laser enucleation of the prostate in patients on anticoagulant therapy or with bleeding disorders. J Urol. 2006 Apr;175(4):1428-32. doi: 10.1016/S0022-5347(05)00645-2.
- 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.
Amy E Krambeck, MD principal investigator
Northwestern Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide in people with BPH With Urinary Obstruction and BPH, run by Northwestern University 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 5 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: looking for participants now, as of the sponsor's last update on 13 Sep 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicholas S Dean, MD (7806906285, nicholas.dean@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Same-day discharge (time frame: 90-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620784, which also lists 4 linked publications.
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 13 Sep 2023.