AzTrials
AzTrials

Benign Prostatic HyperplasiaPhase 2BETTANYNCT06212453

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients With Benign Prostatic Hyperplasia-related Obstruction

A Phase 2 study testing Targeted Microwave Ablation in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Benign Prostatic Hyperplasia
What is being tested?
Targeted Microwave Ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteFrance
Study dates
24 Apr 2024to 15 Jul 2025
Phase
Phase 2
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 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man over 40 years old
  • Indication of surgical management for BPH
  • Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
  • IPSS score ≥15
  • Qmax ≤12 ml/s
  • Affiliated to the French national social security system
Show all 10Show fewer
  • Patient suitable for IV sedation or general anesthesia and focal microwave ablation
  • Wish and able to comply with planned visits
  • Able to express his consent
  • Signed informed consent form

Who cannot join

  • Unwillingness to accept the treatment
  • Neurological pathology responsible for micturition disorders
  • History of prostatic surgery
  • History of prostatic arterial embolization
  • Prostate protrusion Index of grade 2 (>5 mm) or more as evaluated by ultrasonography.
  • Stenosis of the urethra
Show all 11Show fewer
  • History of prostate cancer
  • History of radiotherapy or pelvic surgery
  • Life expectancy <2 years
  • Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
  • Participation in another clinical study involving an investigational product within 1 month before study entry.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Cochin

    Paris, 75014

Other trials in France

About this study

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Read the detailed description

Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks.

To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries.

Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinity™ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.

Being tested
Targeted Microwave Ablation
Keywords
Benign Prostatic Hyperplasia
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted Microwave AblationProcedure or surgery

    3D ultrasound-guided focal thermal ablation of the prostate transition zone

Study groups in NCT06212453
Study groupRoleWhat they receive
patients with BPHExperimentalTargeted Microwave Ablation
Receives: Procedure: Targeted Microwave Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between IPSS score at baseline and at 3 months

    The International Prostate Symptom Score IPSS is a self-questionnaire - It contains seven questions about symptoms related to BPH and one question about the patient's perceived quality of life.

    The seven questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35):

    0-7 Mildly symptomatic - 8-19 Moderately symptomatic - 20-35 Severely symptomatic - Efficacy of the intervention with a decrease of at least 6 points on IPSS score between 3 months and baseline.

    Measured: 3 months

Secondary outcomes (11)

  1. Length of hospital stay

    Measured: 1 month

  2. Need for postoperative bladder catheterization

    Measured: 1 month

  3. Duration of postoperative bladder catheterization

    Measured: 1 month

  4. Postoperative pain

    Visual analogue scale (1 to 10)

    Measured: two hours after surgery

  5. Dimensions of transitional zone tissue ablation

    Measurement on prostatic mpMRI performed at day 7

    Measured: 7 days

  6. Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF)

    4 items to assess ejaculatory functions This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5).

    Measured: 1, 3 and 12 months

  7. International Index of Erectile Function (IIEF-15)

    15 items to assess ejaculatory functions and global sexual life - This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5).

    Measured: 1, 3 and 12 months

  8. IPSS score

    to assess urinary tract symptoms - 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic

    Measured: 1, 3 and 12 months

  9. Urinary Symptom Profile (USP)

    to assess urinary tract symptoms

    Measured: 1, 3 and 12 months

  10. Qmax

    to assess urinary tract symptoms

    Measured: 1, 3 and 12 months

  11. Patients perspectives and treatment preferences

    Characterization of patient motivation to undergo TMA at baseline, as assessed by the patient perspective questionnaire

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start24 Apr 2024
  3. Primary completion15 Jul 2025
  4. Study completion15 Jul 2025

Why it stopped: Due to a lack of recruitment

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Targeted Microwave Ablation
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212453
Sponsor's protocol ID
APHP230759
Other IDs
2023-A02267-38
Acronym
BETTANY
Status last verified
Sep 2026
First submitted
24 Nov 2023
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan JQ, Mao C, Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL. Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015 Jul;94(27):e974. doi: 10.1097/MD.0000000000000974.

    PubMed 26166130

  • Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.

    PubMed 24972732

  • McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.

    PubMed 26614889

  • Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'dow J, Nordling J, de la Rosette JJ; European Association of Urology. EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2013 Jul;64(1):118-40. doi: 10.1016/j.eururo.2013.03.004. Epub 2013 Mar 13.

    PubMed 23541338

  • Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.

    PubMed 25613154

  • Leonardo C, Lombardo R, Cindolo L, Antonelli A, Greco F, Porreca A, Veneziano D, Pastore A, Dalpiaz O, Ceruti C, Verze P, Borghesi M, Schiavina R, Falabella R, Minervini A; AGILE Group. What is the standard surgical approach to large volume BPE? Systematic review of existing randomized clinical trials. Minerva Urol Nefrol. 2020 Feb;72(1):22-29. doi: 10.23736/S0393-2249.19.03589-6. Epub 2019 Oct 10.

    PubMed 31619035

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Targeted Microwave Ablation in people with Benign Prostatic Hyperplasia, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 1 Oct 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to a lack of recruitment). Results are not available in the source record.

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?

Difference between IPSS score at baseline and at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06212453, which also lists 6 linked publications.

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 1 Oct 2026.

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