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NCT Number: NCT04853914

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Adenoma Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Edouard Herriot, service d'urologie

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIFU treatment

Device

HIFU treatment of Benign Prostatic Hyperplasia

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Evaluation of treatment performance by maximum urine output (Qmax)

    Time frame: 1 and 3 months

  2. Evaluation of treatment performance by residual post-void volume (RPM)

    Time frame: 1 and 3 months

  3. Evaluation of voiding symptomatology with IPSS questionnaire

    Time frame: 1 and 3 months

  4. Evaluation of quality of urinary life with Qol-IPSS score

    Time frame: 1 and 3 months

  5. Evaluation of quality of erection with IIEF-5 questionnaire

    Time frame: 1 and 3 months

  6. Evaluation of ejaculation quality with MSHQ-SF questionnaire

    Time frame: 1 and 3 months

  7. Evaluation of continence with ICIQ-SF questionnaire

    Time frame: 1 and 3 months

  8. Evaluation of the global impression of improvement scale with PGI-1 questionnaire

    Time frame: 1 and 3 months

  9. Evaluation of the change in the PSA rate

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

EDAP TMS S.A.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 22, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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