Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

Premature ejaculation (PE) is one of the most common male sexual dysfunctions, often resistant to conventional pharmacological and behavioral treatments. This randomized clinical trial aims to compare the safety and efficacy of two minimally invasive treatment options - hyaluronic acid (HA) injection into the glans penis versus botulinum toxin type A injection into the bulbospongiosus muscle - in men with lifelong drug-resistant premature ejaculation. Eighty participants will be randomly assigned in a 1:1 ratio to receive either HA or botulinum toxin injection. The primary outcome is change in intravaginal ejaculatory latency time (IELT). Secondary outcomes include changes in Premature Ejaculation Diagnostic Tool (PEDT), Arabic Index of Premature Ejaculation (AIPE) scores, Premature Ejaculation Profile (PEP), patient satisfaction, and treatment-related adverse events during a 12-month follow-up period.