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
Recruiting
Phase 2
Interventional Study
Benign Prostatic Hyperplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 22 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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.
Trial Locations
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Eligibility 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 anes…
Contacts