CompletedNot Applicable

Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.

France9 participantsStarted 2021-09-13

Plain-language summary

Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra. Compression of the prostatic urethra by the adenoma can cause lower urinary tract disorders. The classic treatments in case of failure of medical treatment are endoscopic resection of the prostate and adenomectomy, but these techniques are characterized by a significant hemorrhagic risk that may require transfusions and prolonged hospitalization. Minimally invasive treatments with low morbidity have been developed to overcome these drawbacks. They allow to propose a therapeutic solution adapted to patients: not tolerating their medical treatment, wishing to keep antegrade ejaculation, elderly and/or frail, at risk of bleeding, wishing an ambulatory treatment, refusing the conventional surgical techniques. The Focal One® device was developed to treat prostate cancer using ultrasound energy. This energy is delivered through a probe placed in your rectum. Connected to this probe, an ultrasound machine will allow your doctor to see precisely which part of your prostate is being treated. By heating the prostate tissue to a very high temperature in one treatment session, the energy delivered will then destroy the tissue. Ultrasound guidance coupled with the localized nature of the treatment allows the targeted area to be treated while respecting the prostate tissue and structures adjacent to the prostate and thus reducing side effects. Treatment of prostate adenoma with HIFU would allow for localized destruction to reduce prostate volume. The reduction of the compression of the prostatic urethra thus obtained would allow an improvement of the urinary disorders. The treatment is performed transrectally under real-time ultrasound control, which allows the adjacent structures to be respected, thus preserving antegrade ejaculation and limiting the side effects.

Who can participate

Age range

50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Over 50 years of age, * BPH greater than 30 cc confirmed by endorectal ultrasound * IPSS score \> 7, Qol-IPSS \> 2, IIEF-5 score \> 11 * Qmax \< 15 ml/s or urinary retention (in indwelling catheter, self-catheterization, or with an RPM \> 300 cc). * In failure or intolerance of drug treatment(s) for BPH * negative cytobacteriological examination of the urine Exclusion Criteria: * Prostate volume \> 80 ml * Presence of a median lobe * Men allergic to latex * Contraindication to the insertion of a transrectal HIFU probe: rectal fistula, anal or rectal fibrosis, or other abnormalities * History of prostate surgery * History of prostate radiation therapy * History of bladder cancer * Current anti-coagulant treatment with a stopping window that cannot exceed 48 hours at the time of the HIFU procedure * Presence of a urinary tract fistula * History of inflammatory bowel disease * Ongoing urogenital infection * Neurological bladder pathology * History of urethral stenosis * Confirmed or suspected prostate cancer * Contraindication to surgery (including anesthesia) * Contraindication to pelvic MRI * Presence of metallic implants or stents in the urethra * Presence of prostatic calcification whose location interferes with HIFU treatment * Patients with renal failure with a GFR \<35ml/min

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.

Timeframe: 3 months

Trial details

NCT IDNCT04853914

SponsorEDAP TMS S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials