European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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: * To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction; * To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years;

• Prostate volume ≥ 30 mL;

• Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)

• Consent to participate;

Locations
Other Locations
Italy
AOU Careggi
RECRUITING
Florence
Contact Information
Primary
Francesco Sessa
francesco_sessa@hotmail.it
+39 3287305299
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2034-01
Participants
Target number of participants: 2500
Related Therapeutic Areas
Sponsors
Leads: University of Florence

This content was sourced from clinicaltrials.gov