Status:
UNKNOWN
Focal Laser Ablation for Benign Prostatic Hyperplasia
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Eligibility:
MALE
51-85 years
Phase:
NA
Brief Summary
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Detailed Description
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study The aim of this pilot study is to evaluate t...
Eligibility Criteria
Inclusion
- Over 50 years old
- BPH confirmed by mpMRI
- Uroflowmetry indicating obstructive pathology
- Surgical risk moderate-elevated
- Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS)
- Signature of the information sheet and of the informed consent to the treatment, at the execution of the multiparametric MRI and the administration of the paramagnetic contrast medium.
Exclusion
- MRI signs of malignancy confirmed by biopsy investigation
- Urethral stenosis
- Serious coagulation disorders
- Inadequate compliance
- Ischemic pathology in the previous six months
- Presence of pacemakers
- Active phase inflammatory pathology
- Presence of III dominant prostate lobe
- Contraindications to the execution of MRI (claustrophobia, auricular implants, metal prostheses and other contraindications included in the specific informed consent)
- Paramagnetic contrast medium allergy.
- Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / d)
- Not adequate understanding of the information sheet
Key Trial Info
Start Date :
May 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04044573
Start Date
May 5 2018
End Date
April 5 2023
Last Update
August 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
Rome, RM, Italy, 00133