Butterfly Pivotal Study

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)

In brief

A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure

Key facts

Study ID

NCT05341661

Run by

Butterfly Medical Ltd.

People needed

245

Starts

2022-04-07

Expected to finish

2029-12-31

Last updated by the study team

2026-05-29

Who can join

Age: 50 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male patient age 50 and up
• Willing and able to sign informed consent
• Willing and able to comply with all study assessments
• Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).
• Prostate volume 30-90 ml
• Symptomatic BPH: IPSS ≥ 13; ≥ 1 in the IPSS voiding to sub-score ratio (IPSS-V/S)

You may not qualify if…

• Known sensitivity to Nickel.
• Current urinary retention
• Urinary stress incontinence (sphincter)
• Biopsy of the prostate within the last 6 weeks
• Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is < 25% of total PSA in whom cancer was not ruled out by biopsy.
• Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
• Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion).
• Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent.
• Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck)
• Prior surgery or minimal invasive procedure of prostate (brachytherapy and PAE patients are not excluded if they show significant obstruction in urodynamic test and cystoscopy shows no significant fibrosis).
• Currently active bladder tumor or intravesical instillation.
• History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic or atonic bladder, Parkinson's disease, multiple sclerosis, etc.).
• Suspected Neurogenic or atonic urinary bladder.
• Suspected Polyuria/Nocturnal Polyuria.
• Suspected overactive bladder
• High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator
• Urethral pathology: diverticula, strictures, tumors, fistula.
• Acute clinically Significant urinary tract infection.
• Uncontrolled bleeding disorders.
• Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)
• Taking 5 alpha reductase inhibitors within 6 months of baseline evaluation
• Taking one of the following within 2 weeks of baseline evaluation:
• alpha-blockers,
• imipramine,
• anticholinergics,

Where it is running

• Manhattan Medical Research — New York, New York, United States
• Northwell Health — Syosset, New York, United States
• Houston Methodist — Houston, Texas, United States

Full record on ClinicalTrials.gov

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