Phase 1-2 Dose-escalation Study, Evaluating the Safety and Efficacy of the HIFU High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia After 3 Months, 6 Months, 12 Months, 18 Months and 36 Months.

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 obstruction, referred to as lower urinary tract symptoms or LUTS, which become more frequent with age. These symptoms are categorized as obstructive or irritative. In the early stages, men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty. As a result, they need to urinate more often, especially at night, a condition known as nocturia. Additionally, the volume and velocity of the urinary flow may decrease significantly, as evidenced by flow measurements, and residual urine discharge may occur at the end of urination. High-intensity focused ultrasound (HIFU) is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions, including malignant and benign tumors, without the need for invasive surgery or ionizing radiation. HIFU generates heat between 80° to 95°C at the focal point, causing necrosis of the targeted area with pinpoint accuracy. In urology, HIFU is used to treat prostate cancer in a minimally invasive manner, with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring. Exclusively targeted HIFU treatment has been suggested for BPH, where localized necrosis of the side lobes reduces the volume of the prostatic transition zone, alleviating compression of the prostatic urethra and improving urinary symptoms. This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ 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 regularly for more than 12 weeks) OR patient with a contraindication to the initiation of medical treatment OR patient refusing medical treatment Patient whose prostate show no sign of cancerous lesion confirmed by MRI Patient capable of reading and understanding French or with a carer who speaks French and could help the patient understand the leaflet and the questionnaires Patient registered with a social security scheme Patient having given their free and informed consent to participate in the study

Locations
Other Locations
France
Clinique Saint Vincent
NOT_YET_RECRUITING
Besançon
Clinique Tivoli-Ducos
NOT_YET_RECRUITING
Bordeaux
Groupe Hospitalier Pellegrin
NOT_YET_RECRUITING
Bordeaux
CHU de Lille
NOT_YET_RECRUITING
Lille
HCL_Hôpital Edouard Herriot
RECRUITING
Lyon
CH Matigues
RECRUITING
Martigues
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
Clinique Saint Michel
NOT_YET_RECRUITING
Toulon
Hôpitaux de Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Djamila BENNAT
affaires-cliniques@edap-tms.com
33472153142
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 100
Treatments
Experimental: HIFU
Sponsors
Leads: EDAP TMS S.A.

This content was sourced from clinicaltrials.gov