NCT04853914Completed
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 20 Apr 2021
- Start date
- 13 Sept 2021
- Primary completion date
- 31 Aug 2023
- Lead sponsor
- EDAP TMS S.A.
- NCT number
- NCT04853914
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 13 Sept 2021 to the primary completion date, 31 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current anti-coagulant treatment with a stopping window that cannot exceed 48 hours at the time of the HIFU procedure
- Contraindication to surgery (including anesthesia)
- Presence of metallic implants or stents in the urethra
Other illness
- 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
- Presence of a urinary tract fistula
- History of inflammatory bowel disease
- Ongoing urogenital infection
- History of urethral stenosis
- Confirmed or suspected prostate cancer
Lab values
- Patients with renal failure with a GFR \<35ml/min
Other
- Prostate volume \> 80 ml
- Presence of a median lobe
- Neurological bladder pathology
- Contraindication to pelvic MRI
- Presence of prostatic calcification whose location interferes with HIFU treatment
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Edouard Herriot, service d'urologie Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.