Clinical trial NCT04853914: Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
Official title: Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Adenoma
Prostate
HIFU
Mini-invasive treatment
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 9
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional, prospective, mono-centric, non-controlled, non-randomized.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of treatment performance by maximum urine output (Qmax)
timeFrame: 1 and 3 months
measure: Evaluation of treatment performance by residual post-void volume (RPM)
timeFrame: 1 and 3 months
measure: Evaluation of voiding symptomatology with IPSS questionnaire
timeFrame: 1 and 3 months
measure: Evaluation of quality of urinary life with Qol-IPSS score
timeFrame: 1 and 3 months
measure: Evaluation of quality of erection with IIEF-5 questionnaire
timeFrame: 1 and 3 months
measure: Evaluation of ejaculation quality with MSHQ-SF questionnaire
timeFrame: 1 and 3 months
measure: Evaluation of continence with ICIQ-SF questionnaire
timeFrame: 1 and 3 months
measure: Evaluation of the global impression of improvement scale with PGI-1 questionnaire
timeFrame: 1 and 3 months
measure: Evaluation of the change in the PSA rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot, service d'urologie
Study officials:
affiliation: HCL
name: Ricardo Codas-Duarte, DR
role: PRINCIPAL_INVESTIGATOR
References: