Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;
NCT ID: NCT06601179
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-08-23
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
If Phase 1 results indicate that 50% power is insufficient, power levels will be increased by 10% increments (60%, 70%, 80%, 90%) with similar follow-up until the minimum effective dose is determined.
Phase 2 aims to validate the effocacy of the minimum effective dose. It will include 90 new patients treated with the same 50% power. They will be monitored regularly after 1 and 3 months, every 6 months up to 24 months, and finally at 36 months.
TREATMENT
NONE
Study Groups
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HIFU
HIFU
high-intensity focused ultrasound treatment of benign prostatic hyperplasia
Interventions
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HIFU
high-intensity focused ultrasound treatment of benign prostatic hyperplasia
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
Contraindication to the HIFU treatment procedure:
* Active urogenital infection (the infection must be treated before HIFU treatment)
* Anal or rectal fibrosis, anal or rectal stenosis or any other abnormalities making it difficult to insert the Focal One® probe
* Urinary tract or rectal fistula
* Anatomic abnormalities of the rectum or rectal mucosa
* Presence of permanent radioactive implants in the rectal wall
* Presence of prostatic calcification the location of which interferes with the HIFU treatment
* Patient with an artificial sphincter, a penile prosthesis or intra-prostatic implant; for example, an endoprosthesis
* Presence of an implant (stent, catheter) within 1cm of the treatment area
* History of inflammatory bowel disease
* Presence of metal stents or implants in the urethra Patient refusing to participate in the study Person under guardianship considered legally incapable of giving their informed consentPatient unable or refusing to complete the questionnaires Persons placed under judicial protection Subject participating in another study including an exclusion period that is still running at the time of pre-inclusion
50 Years
85 Years
MALE
No
Sponsors
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EDAP TMS S.A.
INDUSTRY
Responsible Party
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Locations
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Clinique Saint Vincent
Besançon, , France
Clinique Tivoli-Ducos
Bordeaux, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU de Lille
Lille, , France
HCL_Hôpital Edouard Herriot
Lyon, , France
CH Matigues
Martigues, , France
Hôpital Foch
Suresnes, , France
Clinique Saint Michel
Toulon, , France
Hôpitaux de Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Vincent Bailly, Dr
Role: backup
Pierre-Charles Henry, Dr
Role: backup
Gilles Pasticier, Dr
Role: backup
Franck Bladou, Pr
Role: backup
Grégoire Robert, Pr
Role: backup
Jonathan Olivier, Dr
Role: backup
Hakim Fassi-Fehri, Dr
Role: backup
Harry Toledano, Dr
Role: backup
Tarek Ghoneim, Dr
Role: backup
Stéphane Mallick
Role: backup
Mathieu Roumiguié, Dr
Role: backup
Other Identifiers
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HIFU.F.23.02
Identifier Type: -
Identifier Source: org_study_id
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