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.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: HIFU treatment

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Jossan; Phone Number: 04 72 15 31 50; Email: Affaires-cliniques@edap-tms.com

Study Locations

• France
  • Lyon, France, 69003
    • Recruiting
    • Hopital Edouard Herriot, service d'urologie
    • Contact: Ricardo Codas-Duarte, Dr
    • Contact: Hakim Fassi-Fehri, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIFU intervention; Patients will benefit of an HIFU treatment of their Benign Prostatic Hyperplasia.	Device: HIFU treatment; HIFU treatment of Benign Prostatic Hyperplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Evaluation of ejaculation quality with MSHQ-SF questionnaire	1 and 3 months
Evaluation of continence with ICIQ-SF questionnaire	1 and 3 months
Evaluation of the global impression of improvement scale with PGI-1 questionnaire	1 and 3 months
Evaluation of the change in the PSA rate	3 months

Collaborators and Investigators

• Sponsor: EDAP TMS S.A.
• Investigators: Principal Investigator: Ricardo Codas-Duarte, DR, HCL

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adenoma; Prostate; HIFU; Mini-invasive treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: HIFU/F/20.09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No