High-intensity Focused Ultrasound treatment for enlarged prostate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of High-intensity Focused Ultrasound (HIFU) as a treatment for benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate that affects urinary flow. The study targets men aged 50 to 85 who have been diagnosed with BPH and have not responded to medical treatments. Participants will undergo HIFU treatment, and their urinary symptoms will be assessed to determine the effectiveness of this non-invasive approach. The trial aims to provide an alternative treatment option for men suffering from lower urinary tract symptoms due to BPH.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Men aged ≥ 50 to ≤ 85

Patient diagnosed with benign prostatic hyperplasia evaluated by:

* Prostate volume ranging from 30 cc to 80 cc evaluated by MRI
* Qmax \< 15ml/s
* IPSS ≥ 8
* IPSS-QoL ≥ 3
* IIEF-5 \> 17

Patient for whom medical treatment failed (having been taken regularly for more than 12 weeks) OR patient with a contraindication to the initiation of medical treatment OR patient refusing medical treatment Patient whose prostate show no sign of cancerous lesion confirmed by MRI Patient capable of reading and understanding French or with a carer who speaks French and could help the patient understand the leaflet and the questionnaires Patient registered with a social security scheme Patient having given their free and informed consent to participate in the study

Exclusion Criteria:

Presence of a median lobe preventing the HIFU treatment to be delivered according to the investigator's judgment Prostate cancer confirmed or suspected History of surgical treatment of the prostate History of radiotherapy of the prostate History of bladder cancer History of urethral stricture Presence of a urinary tract fistula Urethral stricture or untreated bladder neck stenosis Untreated urinary lithiasis Neurological bladder or neurological bladder disease or any other neurological disease likely to affect the functioning of the bladder-sphincter system History of pelvic radiotherapy Patient with renal failure with GFR \< 35ml/min Patient currently undergoing anticoagulant therapy (antivitamins K (AVK) and new oral anticoagulants (NOACs) for which the stop window cannot exceed 48H at the time of the HIFU procedure Contraindication to the surgical procedure, in particular anesthesia Contraindication to the pelvic MRI Patient with a rectal wall \> 10mm

Contraindication to the HIFU treatment procedure:

* Active urogenital infection (the infection must be treated before HIFU treatment)
* Anal or rectal fibrosis, anal or rectal stenosis or any other abnormalities making it difficult to insert the Focal One® probe
* Urinary tract or rectal fistula
* Anatomic abnormalities of the rectum or rectal mucosa
* Presence of permanent radioactive implants in the rectal wall
* Presence of prostatic calcification the location of which interferes with the HIFU treatment
* Patient with an artificial sphincter, a penile prosthesis or intra-prostatic implant; for example, an endoprosthesis
* Presence of an implant (stent, catheter) within 1cm of the treatment area
* History of inflammatory bowel disease
* Presence of metal stents or implants in the urethra Patient refusing to participate in the study Person under guardianship considered legally incapable of giving their informed consentPatient unable or refusing to complete the questionnaires Persons placed under judicial protection Subject participating in another study including an exclusion period that is still running at the time of pre-inclusion

Where it's running

• HCL_Hôpital Edouard Herriot
  Lyon, France Recruiting
• CH Matigues
  Martigues, France Recruiting
• Clinique Saint Vincent
  Besançon, France Not yet recruiting
• Clinique Tivoli-Ducos
  Bordeaux, France Not yet recruiting
• Groupe Hospitalier Pellegrin
  Bordeaux, France Not yet recruiting
• CHU de Lille
  Lille, France Not yet recruiting

Study contacts

• Study coordinator: Djamila BENNAT
• Email: affaires-cliniques@edap-tms.com
• Phone: 33472153142

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sonablate HIFU Registry for Prostate Cancer and BPH

  This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.

  Recruiting Sonablate · Indianapolis, Indiana · NCT07757490

• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

  This study tests whether adding tadalafil to tamsulosin helps men with BPH see better urinary symptoms and quality of life, using two tadalafil doses over 12 weeks.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07722884

• MRI-DTI look at the urethral sphincter ring and prostate base shape

  This imaging study tests how the male urethral internal sphincter ring appears on MRI-DTI and how it relates to prostate base morphology in men undergoing clinically indicated MRI.

  Recruiting Jiangsu Taizhou People's Hospital · Taizhou, Jiangsu · NCT07694752

• Tamsulosin With or Without Tadalafil for a Trial Without Catheter After Acute Urinary Retention

  This study tests whether adding tadalafil to tamsulosin helps men with a first episode of acute urinary retention due to enlarged prostate pass urine without needing a catheter.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07654413

• Tamsulosin dose change or switch to silodosin before catheter removal in men with BPH-related acute urinary retention

  This trial tests whether continuing tamsulosin, increasing its dose, or switching to silodosin helps men with BPH-related acute urinary retention go without a catheter after seven days.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07650968

• Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

  This study tests whether Water Vapor Thermal Therapy (Rezum) or an ejaculation-sparing enucleation procedure better helps sexually active men with bothersome BPH symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.