Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients Who Completed 12 Months of Follow-Up Post Implantation (Continuation Study for Study BM-011-IL)

Butterfly Medical

Status: Enrolling

Conditions: BOO - Bladder Outflow Obstruction; BPH; Enlarged Prostate (BPH)

Treatments: Procedure: Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05330520

BM-011-LT

Details and patient eligibility

About

This study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 5 year after implantation.

The evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests, residual urine and International Prostate Symptom Score (IPSS) questionnaires. The study also assesses the sexual quality of life after implantation of the Butterfly device.

Full description

Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder.

BPH is a proliferative process of the cellular elements of the prostate, also referred as enlarged prostate. Cellular accumulation and gland enlargement may be due to epithelial and stromal proliferation, impaired pre-programmed cell death (apoptosis), or both. More recently, the voiding dysfunction that ensues from prostate gland enlargement and bladder outlet obstruction (BOO) has been generically termed lower urinary tract symptoms (LUTS). These entities overlap; not all men with BPH have LUTS, and, likewise, not all men with LUTS have BPH. The same can be said for BOO.

An estimated 50% of men demonstrate histopathologic BPH by age 60 years. This number increases to 90% by age 85 years; thus, increasing gland size is considered a normal part of the aging process (2-5).

Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe LUTS. Clinical manifestations of LUTS include urinary frequency, urgency, nocturia (getting up at night during sleep to urinate), decreased or intermittent force of stream, or a sensation of incomplete emptying. Complications occur less commonly but may include acute urinary retention, impaired bladder emptying, or the need for surgery.

The Butterfly Medical Prostatic Retraction Device is a retraction device, specially designed to be delivered into the prostatic urethra and indicated to dilate the prostatic urethra in BPH patients. This device was specially designed to reduce most of the known complications of used urethral stents.

The current clinical study is aimed to investigate the long term technical performance and clinical usage of Butterfly Medical Prostatic Retraction Device, through a 4 year follow up period, as a continuation of study BM-011-IL which assessed the above for a duration of 12 month post implantation.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Completed 12 months follow up under study BM-011-IL. A subject that missed one or more visits during BM-011-IL will be included, as long as the subject has collected data at 12 months follow up visit.
2. Provide signed informed consent to the continuation study and be willing and able to perform follow up visits and activities as described in the study protocol.

Exclusion criteria

1. Patients which participated in the BM-011-IL study and did not complete 12 months follow up visit under study BM-011-IL due to any reason

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation

Experimental group

Description:

Continuation study for Study BM-011-IL

Treatment:

Procedure: Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement

Sponsor of this trial

Lead Sponsor

Butterfly Medical