Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;

Recruiting N/A Interventional Study
Benign Prostatic Hyperplasia
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 – 85
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
EDAP TMS S.A. · Industry
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About This Trial
Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. The risk of BPH is more than 50% in men aged 50 to 60 and rises to 90% in men by age 80. This hyperplasia leads to altered urinary flow and bladder outlet…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Men aged ≥ 50 to ≤ 85 Patient diagnosed with benign prostatic hyperplasia evaluated by: * Prostate volume ranging from 30 cc to 80 cc evaluated by MRI * Qmax \< 15ml/s * IPSS ≥ 8 * IPSS-QoL ≥ 3 * IIEF-5 \> 17 Patient for whom medical treatment failed (having been taken regula…
Contacts

Djamila BENNAT

33472153142

affaires-cliniques@edap-tms.com

CONTACT