Lower Urinary Tract Symptoms Clinical Trial
Official title:
Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study - Results at 6 and 12 Months From a Retrospective Multi-centric Study
Verified date | December 2019 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigated the effectiveness and safety of SoracteLite ™- Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic Benign Prostatic Hyperplasia (BPH) at 6 and 12 months follow-up
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | March 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Male - = 50 years of age - International Prostate Symptoms (IPSS) =12 - Peak urinary flow rate (Qmax): <15 ml - Prostate volume: = 30 ml, measured by transrectal ultrasound - Post-void residual (PVR): <400 ml - Signed informed consent Exclusion Criteria: - MRI signs of malignancy confirmed by biopsy investigation - urethral stenosis - serious coagulation disorders - inadequate compliance - ischemic pathology in the previous six months - active phase inflammatory pathology |
Country | Name | City | State |
---|---|---|---|
Italy | Casa di Cura Santa Rita | Atripalda | AV |
Italy | IGreco Ospedali Riuniti | Cosenza | |
Italy | Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology | Rome | RM |
Italy | ASST Bergamo Est | Seriate | BG |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata | European Institute of Oncology, Ospedale Regina Apostolorum |
Italy,
Bremer 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. — View Citation
Costello 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. — View Citation
Goldberg 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. — View Citation
Lindner 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. — View Citation
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. — View Citation
Raz 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. Erratum in: Eur Urol. 2010 Sep;58(3):473. Kucharcyzk, Walter [corrected to Kucharczyk, Walter]. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical symptoms changes at 6 months and 12 months follow-up evaluated with 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 | |
Secondary | Treatment safety measured by complications incidence | Number of incidence of Complication according to modified Clavien classification system | 30 days |
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