Phase
Condition
Prostate Disorders
Bladder Disorders
Treatment
HIFU treatment
Clinical Study ID
Ages > 50 Male
Study Summary
Eligibility Criteria
Inclusion
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
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, analor 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 hoursat 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 Design
Connect with a study center
Hopital Edouard Herriot, service d'urologie
Lyon, 69003
FranceSite Not Available

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