NCT05620784 Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
| NCT ID | NCT05620784 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Northwestern University |
| Condition | BPH With Urinary Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2023-06-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 138 participants in total. It began in 2023-03-01 with a primary completion date of 2023-06-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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. .
Eligibility Criteria
Inclusion Criteria: * Males 18 -89 undergoing HoLEP * Willing to sign the Informed Consent Form * Able to read, understand, and complete patient questionnaires. Exclusion Criteria: * 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
Contact & Investigator
Amy E Krambeck, MD
PRINCIPAL INVESTIGATOR
Northwestern Medicine
Frequently Asked Questions
Who can join the NCT05620784 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 89 Years, studying BPH With Urinary Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05620784 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 138 participants.
Is NCT05620784 currently recruiting?
Yes, NCT05620784 is actively recruiting participants. Contact the research team at nicholas.dean@northwestern.edu for enrollment information.
Where is the NCT05620784 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05620784 clinical trial?
NCT05620784 is sponsored by Northwestern University. The principal investigator is Amy E Krambeck, MD at Northwestern Medicine. The trial plans to enroll 138 participants.