Holmium Laser Enucleation of the Prostate (HoLEP): A Technical Update.
Ramsay L Kuo, Ryan F Paterson, Samuel C Kim...
https://pubmed.ncbi.nlm.nih.gov/12818001/Actively Recruiting
Led by Northwestern University · Updated on 2023-09-13
138
Participants Needed
1
Research Sites
60 weeks
Total Duration
Researchers are evaluating the use of intravenous loop diuretics, specifically 20mg of furosemide, during Holmium Laser Enucleation of the Prostate HoLEP for men with benign prostatic hypertrophy BPH. HoLEP is recognized as a size-independent treatment for BPH and is recommended by the American Urological Association. The study aims to determine if giving furosemide during the morcellation phase affects the rates of same-day discharge after surgery. In this randomized, double-blind trial, participants are assigned to receive either 20mg of IV furosemide during the morcellation phase of their HoLEP procedure or no furosemide during this phase. The purpose is to compare how these two approaches influence recovery and discharge timing. Patients, surgeons, and care teams remain unaware of the group assignments to ensure unbiased results. Participants will be monitored for outcomes such as same-day discharge rates and same-day catheter removal within 90 days after surgery. Researchers will also track adverse events like hematuria and fluid absorption, operative efficiency, length of hospital stay, and overall complications. The study includes patient questionnaires and follows patients for safety and recovery over a 90-day period.
CONDITIONS
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
N
Nicholas S Dean, MD
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Northwestern University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intra-operative Furosemide (IV) During HoLEP | Standard HoLEP Without Diuretic |
|---|---|---|
| What it is | Single dose of intravenous furosemide (20mg) given during the morcellation phase of HoLEP surgery. | Standard HoLEP surgical management without additional intra-operative diuretic administration. |
| Role in trial | Intervention group: eligible patients receive intra-operative loop diuretic to test its effect on same-day discharge rates. | Control group: patients undergo HoLEP surgery managed as per current hospital standard, with no additional diuretic. |
| Primary use | Evaluates if intra-operative furosemide supports higher rates of same-day patient discharge following HoLEP. | Represents current HoLEP care, benchmarking same-day discharge outcomes without additional intra-operative diuretic. |
| How it is given or performed | A single 20mg IV dose of furosemide is administered during the morcellation phase after enucleation of prostate tissue. | No IV diuretic is given; surgery is performed per standard HoLEP protocol without additional intervention. |
| Evidence status | No published efficacy results are available yet for intra-operative furosemide use during HoLEP. | HoLEP is well-established as an effective surgical treatment for BPH, with published data showing most patients can be safely discharged the same day postoperatively. |
| Important limitations | As this use of furosemide is investigational, risks specific to intra-operative administration or effects on electrolyte/fluid balance in the surgical setting are not yet fully characterized; results for efficacy and safety are pending. | Although same-day discharge is often possible after HoLEP, some patients may still require longer monitoring due to bleeding risk, difficulties with voiding, or other postoperative factors. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo Holmium Laser Enucleation of the Prostate (HoLEP) with or without the administration of 20mg of IV furosemide during the morcellation phase.
1 surgery visit (in-person)
Duration - Up to 90 days post-surgery
Participants are monitored for recovery, hematuria, catheter removal, and complications after surgery.
Follow-up visits as per routine care, including catheter removal and monitoring
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/32698710/Northwestern University
Lead Sponsor