Randomized controlled trial comparing deep dermal glanular hyaluronic acid injection versus oral dapoxetine in management of premature ejaculation.

BACKGROUND

Premature ejaculation (PE) is a common male sexual dysfunction with significant psychosocial consequences. Available treatment options include behavioral therapy, topical agents, and pharmacological interventions. This randomized controlled trial aims to compare the efficacy and safety of deep dermal glanular hyaluronic acid (HA) injection versus oral dapoxetine in men with lifelong PE refractory to behavioral therapy.

RESULTS

Sixty men aged ≥ 18 years were randomly assigned to receive either oral dapoxetine 60 mg three times weekly (Group A) or HA injection into the glans penis (Group B). The primary endpoint was the change in intravaginal ejaculation latency time (IELT) at 6 months following treatment initiation, while secondary outcomes included International Index of Erectile Function-5 (IIEF-5), Index of Premature Ejaculation (IPE), quality of life (QoL), patient satisfaction, and adverse events. Assessments were conducted at baseline and at 1, 3, and 6 months. Both groups demonstrated significant improvements in IELT, IIEF-5, IPE, and QoL at all follow-up time points compared with baseline (p < 0.05). However, improvements were significantly greater in the HA group at 1, 3, and 6 months (p < 0.05). Patient satisfaction was consistently higher in the HA group throughout follow-up (p < 0.05). Adverse events in the dapoxetine group included nausea, dizziness, headache, and dry mouth, whereas the HA group experienced transient injection-site pain, ecchymosis, and bullae formation.

CONCLUSION

Deep dermal glanular hyaluronic acid injection is more effective than oral dapoxetine in improving ejaculatory control, sexual function, and quality of life in men with lifelong PE, with an acceptable safety profile.