A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients

Butterfly Medical Ltd.3 sites in 1 country245 target enrollmentApril 7, 2022

ConditionsBPH (Benign Prostatic Hyperplasia)Lower Urinary Tract Symptoms (LUTS)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: BPH (Benign Prostatic Hyperplasia)
Sponsor: Butterfly Medical Ltd.
Enrollment: 245
Locations: 3
Primary Endpoint: Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 7, 2022

End Date

December 31, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Butterfly Medical Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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).