Status:
COMPLETED
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
Lead Sponsor:
EDAP TMS S.A.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
NA
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. Comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04853914
Start Date
September 13 2021
End Date
March 31 2024
Last Update
June 5 2025
Active Locations (1)
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1
Hopital Edouard Herriot, service d'urologie
Lyon, France, 69003