NCT05366504

LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment

Is Combined Low Intensity Shockwave Therapy (LiST) Plus Platelet-rich Plasma (PRP) Injection Therapy Better Than LiST Monotherapy for the Improvement of Erectile Function? a Double-blind, Randomized, Placebo-controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institute for the Study of Urological Diseases, Greece · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

We designed a double blind randomized sham-controlled trial in order to investigate and compare the treatment efficacy of LiST plus PRP intracorporeal injection vs LiST plus placebo (normal saline intracorporeal injection) in men with moderate and mild to moderate vasculogenic ED, as measured by IIEF-EF.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LiST + PRP intracorporeal injection	12 LiST sessions (2 sessions per week) plus PRP (2 intracorporeal injections 3 weeks apart, after the 1st and the 7th LiST sessions) ( 30 patients).
COMBINATION_PRODUCT	LiST + Placebo(normal saline intracorporeal injection)	All subjects of this group will receive 12 sessions (V3-V14) of LiST with session frequency 2/week and 2 normal saline injections with 3 weeks treatment interval (V3 and V9), 10 ml of normal saline will be injected at each session.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2024-03-01
• First posted: 2022-05-09
• Last updated: 2022-05-09