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

NCT04853914 | Completed DMC

• 1 other identifier: HIFU/F/20.09
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Adenoma; Prostate; HIFU; Mini-invasive treatment

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (9)

• Evaluation of treatment performance by maximum urine output (Qmax)

  1 and 3 months

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

  1 and 3 months

• Evaluation of voiding symptomatology with IPSS questionnaire

  1 and 3 months

• Evaluation of quality of urinary life with Qol-IPSS score

  1 and 3 months

• Evaluation of quality of erection with IIEF-5 questionnaire

  1 and 3 months

Study Arms (1)

HIFU intervention

EXPERIMENTAL

Patients will benefit of an HIFU treatment of their Benign Prostatic Hyperplasia.

Device: HIFU treatment

Interventions

HIFU treatment DEVICE

HIFU treatment of Benign Prostatic Hyperplasia

HIFU intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (1)

Hopital Edouard Herriot, service d'urologie

Lyon, 69003, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Adenoma

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ricardo Codas-Duarte, DR

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, prospective, mono-centric, non-controlled, non-randomized.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: September 13, 2021
• Primary Completion: August 31, 2023
• Study Completion: March 31, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)