Evaluating a new treatment for urinary symptoms caused by prostate enlargement
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
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT06212453
This study is testing a new microwave treatment for men with urinary problems caused by an enlarged prostate to see if it works better and is safer than traditional surgery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06212453 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of transperineal focal microwave ablation (TMA) for treating lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). It is a prospective pilot study conducted at a single institution, focusing on a minimally invasive approach that utilizes 3D ultrasound guidance for precision. The study compares this new method to traditional surgical interventions, which often come with significant complications. By using microwave thermal ablation, the researchers hope to provide a safer and more effective treatment option for patients suffering from BPH-related obstruction.
Who should consider this trial
Good fit: Ideal candidates are men over 40 with moderate to severe BPH symptoms and specific prostate volume criteria.
Not a fit: Patients with a history of prostate cancer or those who have undergone previous prostate surgeries may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and improve quality of life for patients with BPH.
How similar studies have performed: While similar minimally invasive techniques have shown promise, this specific approach using TMA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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.
Where this trial is running
Paris
- Hôpital Cochin — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Nicolas BARRY DELONGCHAMPS, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Nicolas BARRY DELONGCHAMPS, MD, PHD
- Email: nicolas.barry-delongchamps@aphp.fr
- Phone: +33 1 58 41 27 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia