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

Hyaluronic Acid Versus Botox Injection in Treatment of Life Long Drug Resistant Premature Ejaculation. Which is Better? 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.

Inclusion Criteria:

• Adult male patients aged 22 to 45 years.
• Sexually active and in a stable heterosexual relationship.
• Circumcised.
• Able to understand and comply with study procedures and follow-up visits.
• Diagnosed with lifelong drug-resistant premature ejaculation, defined as persistent ejaculation within one minute of penetration despite prior pharmacologic or behavioral therapy.
• Normal serum total testosterone, prolactin, and thyroid-stimulating hormone levels.
• Willing to provide written informed consent.

Exclusion Criteria:

• Presence or history of erectile dysfunction or other sexual or ejaculatory disorders such as retrograde ejaculation or acquired premature ejaculation.
• History of acute or chronic prostatitis.
• Any debilitating medical condition including hepatic failure, renal failure, or uncontrolled diabetes mellitus.
• Previous pelvic or spinal surgery.
• Prior chemotherapy or radiotherapy.
• Use of antipsychotic or neuroactive medications that may affect ejaculation.
• History of substance abuse or current drug dependence.
• Presence of penile prosthesis, penile deformity, or anatomic abnormalities of the glans or shaft.
• Known hypersensitivity or allergy to botulinum toxin or hyaluronic acid preparations.
• Any condition that, in the investigator's opinion, may interfere with the safety or evaluation of the study treatment.