The Butterfly Prostatic Retraction device is currently under investigation in a prospective pivotal trial (NCT05341661) in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH).1
In a recent interview with Urology Times®, Bilal I. Chughtai, MD, walked through the design and potential implications of the trial for clinical practice. Chughtai is the chief of urology at Plainview Hospital at Northwell Health in Syosset, New York.
The study has completed enrollment at 245 patients. To be eligible for enrollment, patients needed to be aged 50 years or older and have a prostate length between 25 mm to 45 mm, a prostate volume between 30 to 90 mL, and symptomatic BPH.
Those included in the study were randomly assigned 2:1 to receive the Butterfly device or a sham comparator. Patients in the sham arm are able to crossover to the treatment arm at 3 months.
The primary end points for the study include change in International Prostate Symptom Score at 3 months and 12 months. Primary completion of the trial is expected in December 2025.
During the discussion, Chughtai also touched on the potential impact of this device if approved, saying, “Once we have a device like this, I think we’re going to see a paradigm-shift. I think there’s going to be shift away from medications, which have been shown to have additional effects…These meds aren’t as safe as we thought.”
He added, “I think this is going to fill a niche where patients can get an option that is local, reversible, and get decent relief.”
REFERENCE
1. Butterfly pivotal study. ClinicalTrials.gov. Last updated January 15, 2025. Accessed July 6, 2025. https://clinicaltrials.gov/study/NCT05341661