NCT05784909 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B
Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Can J Urol. 2021 Oct;28(5):10824-10833.
Garden EB, Shukla D, Ravivarapu KT, Kaplan SA, Reddy AK, Small AC, Palese MA
Rezum therapy for patients with large prostates (>/= 80 g): initial clinical experience and postoperative outcomes. World J Urol. 2021 Aug;39(8):3041-3048. doi: 10.1007/s00345-020-03548-7. Epub 2021 Jan 3.
Kim EH, Larson JA, Andriole GL
Management of Benign Prostatic Hyperplasia. Annu Rev Med. 2016;67:137-51. doi: 10.1146/annurev-med-063014-123902. Epub 2015 Sep 2.
Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C
Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.
Vuichoud C, Loughlin KR
Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol. 2015 Oct;22 Suppl 1:1-6.
Zhang SJ, Qian HN, Zhao Y, Sun K, Wang HQ, Liang GQ, Li FH, Li Z
Relationship between age and prostate size. Asian J Androl. 2013 Jan;15(1):116-20. doi: 10.1038/aja.2012.127. Epub 2012 Dec 10.

Outcomes of Water Vapor Thermal Therapy (REZUM) in Management of Symptomatic Patients With Benign Prostatic Enlargement

Clinical trial NCT05784909 - References