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

Sponsor

EDAP TMS S.A. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04853914

Collaborator

(none)

Enrollment

Location

Arm

8.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Device: HIFU treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Interventional, prospective, mono-centric, non-controlled, non-randomized.Interventional, prospective, mono-centric, non-controlled, non-randomized.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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