An observational study in Benign Prostatic Hyperplasia and Prostatic Diseases, sponsored by University of Florence. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University of Florence · Observational
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.
Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.
Secondary objectives of the study are:
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University of Florence is the lead sponsor of 76 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred to the centers participating in the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Transperineal Laser Ablation of the Prostate is an ultra minimally-invasive procedure that consists in the insertion trough the perineum skin of laser fibers into the prostatic adenoma, under US guidance. Laser energy generates an area of coagulative necrosis that will bring to a reduction of the prostatic volume.
Rate of partecipants needing for other surgery
Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy)
Time frame: 5 years
Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale
Number of Participants with Treatment-Related Adverse Events as Assessed by Clavien-Dindo scale (score from I to V - higher scores mean a worse outcome)
Time frame: 6 months
Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index
Number of Participants with Treatment-Related Adverse Events as Assessed by Comprehensive Complication Index. The Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)
Time frame: 6 months
Change from Baseline in the International Prostatic Symptoms Score (IPSS)
Patient-reported outcome measure about urinary symptoms evaluated by International Prostatic Symptoms Score (IPSS) - values from 0 to 35 (higher scores mean a worse outcome)
Time frame: 5 years
Change from Baseline in the IPSS - Quality of Life score
Patient-reported outcome measure about impact of urinary symptoms on quality of life evaluated by IPSS - Quality of Life (QoL) questionnaire (values from 0 to 6 - higher scores mean a worse outcome)
Time frame: 5 years
Change from Baseline in the International Index of Erectile Function (IIEF-5)
Patient-reported outcome measure about erectile function evaluated by International Index of Erectile Function (IIEF-5) - values from 0 to 25 (higher values mean a better outcome)
Time frame: 5 years
Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)
Patient-reported outcome measure about impact of ejaculatory disfunctions in quality of life evaluated by Male Sexual Health Questionnaire bother (MSHQ bother) - values from 0 to 5 (higher scores mean a worse outcome)
Time frame: 5 years
Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)
Patient-reported outcome measure about ejaculatory function evaluated by Male Sexual Health Questionnaire 3-items (MSHQ 3-items) - values from 0 to 15 (higher scores mean a better outcome)
Time frame: 5 years
Change from Baseline in maximum flow rate (ml/s)
Change from Baseline in maximum flow rate (ml/s) evaluated at uroflowmetry
Time frame: 5 years
Change from Baseline in post void residual volume (ml)
Change from Baseline in post void residual volume (ml) evaluated with sovrapubic ultrasound or bladderscan after spontaneous micturition
Time frame: 5 years
Plan to share: Undecided
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University of Florence