Benign Prostatic HyperplasiaNCT04853914
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
A study testing HIFU treatment in people with Benign Prostatic Hyperplasia, run by EDAP TMS S.A. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- HIFU treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- HIFU treatment
- Keywords
- Adenoma, Prostate, HIFU, Mini-invasive treatment
- Medical subject headings
- Prostatic Hyperplasia, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFU treatmentDevice
HIFU treatment of Benign Prostatic Hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| HIFU intervention | Experimental | Patients will benefit of an HIFU treatment of their Benign Prostatic Hyperplasia. Receives: Device: HIFU treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.
Measured: 3 months
Secondary outcomes (9)
Evaluation of treatment performance by maximum urine output (Qmax)
Measured: 1 and 3 months
Evaluation of treatment performance by residual post-void volume (RPM)
Measured: 1 and 3 months
Evaluation of voiding symptomatology with IPSS questionnaire
Measured: 1 and 3 months
Evaluation of quality of urinary life with Qol-IPSS score
Measured: 1 and 3 months
Evaluation of quality of erection with IIEF-5 questionnaire
Measured: 1 and 3 months
Evaluation of ejaculation quality with MSHQ-SF questionnaire
Measured: 1 and 3 months
Evaluation of continence with ICIQ-SF questionnaire
Measured: 1 and 3 months
Evaluation of the global impression of improvement scale with PGI-1 questionnaire
Measured: 1 and 3 months
Evaluation of the change in the PSA rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start13 Sep 2021
- Primary completion31 Aug 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective, mono-centric, non-controlled, non-randomized.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- EDAP TMS S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Codas-Duarte, DR, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853914
- Sponsor's protocol ID
- HIFU/F/20.09
- Status last verified
- Jun 2025
- First submitted
- 20 Apr 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
- ClinicalTrials.gov ID
- NCT04853914
- Acronym / sponsor ID
- HIFU/F/20.09
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Adenoma, Prostate, HIFU, Mini-invasive treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- EDAP TMS S.A.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective, mono-centric, non-controlled, non-randomized.
| Arm | Type | Receives |
|---|---|---|
| HIFU intervention | Experimental | Device: HIFU treatmentPatients will benefit of an HIFU treatment of their Benign Prostatic Hyperplasia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFU treatmentHIFU treatment of Benign Prostatic Hyperplasia | Device | HIFU intervention |
Primary outcome
The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up.
Time frame: 3 months
9 secondary outcomes
Evaluation of treatment performance by maximum urine output (Qmax)
Time frame: 1 and 3 months
Evaluation of treatment performance by residual post-void volume (RPM)
Time frame: 1 and 3 months
Evaluation of voiding symptomatology with IPSS questionnaire
Time frame: 1 and 3 months
Evaluation of quality of urinary life with Qol-IPSS score
Time frame: 1 and 3 months
Evaluation of quality of erection with IIEF-5 questionnaire
Time frame: 1 and 3 months
Evaluation of ejaculation quality with MSHQ-SF questionnaire
Time frame: 1 and 3 months
Evaluation of continence with ICIQ-SF questionnaire
Time frame: 1 and 3 months
Evaluation of the global impression of improvement scale with PGI-1 questionnaire
Time frame: 1 and 3 months
Evaluation of the change in the PSA rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Codas-Duarte, DR principal investigator
HCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU treatment in people with Benign Prostatic Hyperplasia, run by EDAP TMS S.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of HIFU treatment will be assessed by analyzing adverse events (serious and non-serious) reported during follow-up. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.