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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 Ltd. · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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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.
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