Focal Laser Ablation for Benign Prostatic Hyperplasia
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
1 other identifier
interventional
40
1 country
1
Brief Summary
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2018
CompletedFirst Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2023
CompletedAugust 5, 2019
August 1, 2019
4.9 years
July 11, 2019
August 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume.
12 months
Rate of complication needing re-hospitalisation or reintervention
Evaluation of complications post TPLA treatment by MRI.
procedure date to 12 months
Secondary Outcomes (4)
Reproducibility of Multi-parametric MRI
12 months.
Total and post-operative costs during follow-up compared to transurethral resection of the prostate
12 months
Evaluation of Quality of Life by International Prostate Symptom Score
12 months
Evaluation of Quality of Life by International Index of Erectile Function
12 months
Study Arms (1)
ECHOLASER X4 Socratelite
EXPERIMENTALOptic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.
Interventions
The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
Rome, RM, 00133, Italy
Related Publications (7)
Patelli G, Ranieri A, Paganelli A, Mauri G, Pacella CM. Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. Cardiovasc Intervent Radiol. 2017 Sep;40(9):1440-1446. doi: 10.1007/s00270-017-1662-9. Epub 2017 May 4.
PMID: 28474112BACKGROUNDRaz O, Haider MA, Davidson SR, Lindner U, Hlasny E, Weersink R, Gertner MR, Kucharczyk W, McCluskey SA, Trachtenberg J. Real-time magnetic resonance imaging-guided focal laser therapy in patients with low-risk prostate cancer. Eur Urol. 2010 Jul;58(1):173-7. doi: 10.1016/j.eururo.2010.03.006. Epub 2010 Mar 12.
PMID: 20334965BACKGROUNDLindner U, Weersink RA, Haider MA, Gertner MR, Davidson SR, Atri M, Wilson BC, Fenster A, Trachtenberg J. Image guided photothermal focal therapy for localized prostate cancer: phase I trial. J Urol. 2009 Oct;182(4):1371-7. doi: 10.1016/j.juro.2009.06.035. Epub 2009 Aug 14.
PMID: 19683262BACKGROUNDGoldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais D, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG; Society of Interventional Radiology Technology Assessment Committee. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2005 Jun;16(6):765-78. doi: 10.1097/01.RVI.0000170858.46668.65.
PMID: 15947040BACKGROUNDBremer C, Kreft G, Roggan A, Filler T, Reimer P. Ex vivo evaluation of novel miniaturized laser-induced interstitial thermotherapy applicators for effective small-volume tissue ablation. Invest Radiol. 2001 Jun;36(6):327-34. doi: 10.1097/00004424-200106000-00005.
PMID: 11410753BACKGROUNDCostello AJ, Bowsher WG, Bolton DM, Braslis KG, Burt J. Laser ablation of the prostate in patients with benign prostatic hypertrophy. Br J Urol. 1992 Jun;69(6):603-8. doi: 10.1111/j.1464-410x.1992.tb15631.x.
PMID: 1379101BACKGROUNDManenti G, Perretta T, Calcagni A, Ferrari D, Ryan CP, Fraioli F, Meucci R, Malizia A, Iacovelli V, Agro EF, Floris R. 3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. Eur Radiol Exp. 2021 Sep 17;5(1):41. doi: 10.1186/s41747-021-00239-9.
PMID: 34532768DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2019
First Posted
August 5, 2019
Study Start
May 5, 2018
Primary Completion
April 5, 2023
Study Completion
April 5, 2023
Last Updated
August 5, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- This registry will be open for inclusion for five years. Since individual patients will have a follow-up of five years, the total study duration will be 10 years.
- Access Criteria
- Every accredited centre that performs TPLA procedures, wants to participate and signs the regulatory document and obtains ethical committee approval can participate
Create an international registry to assess long-term effectiveness of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.