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New treatment option for Benign Prostatic Hyperplasia
Official title 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
ClinicalTrials.gov ID: NCT06212453
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.