# Evaluation of the Efficacy and Safety of On-Demand Tadalafil Alone or Combined With Lidocaine Spray for Treating Patients With Comorbid Erectile Dysfunction and Premature Ejaculation: A Randomized Controlled Trial

## TL;DR

This study compares tadalafil alone versus tadalafil plus lidocaine spray for treating erectile dysfunction and premature ejaculation, finding that the combination improves sexual outcomes more effectively.

## Contribution

The study introduces a novel combination therapy of tadalafil and lidocaine spray for comorbid ED and PE, showing superior efficacy compared to tadalafil alone.

## Key findings

- Combination therapy significantly improved premature ejaculation scores and increased intravaginal ejaculation latency time.
- The combination group showed significant sexual satisfaction improvements compared to tadalafil alone.
- Both groups had similar safety profiles with no significant difference in adverse events.

## Abstract

To evaluate the efficacy and safety of on-demand 20 mg tadalafil alone or combined with lidocaine spray for treating patients with comorbid erectile dysfunction (ED) and premature ejaculation (PE).

This randomized controlled trial included 98 patients with comorbid ED and PE, randomly assigned to the experimental group (n = 50, tadalafil alone) or the active control group (n = 48, tadalafil combined with lidocaine spray). Patients took tadalafil 30 min before sexual intercourse, while the combination therapy group also used lidocaine spray 5 min before intercourse. After 12 weeks of treatment, changes in the International Index of Erectile Function (IIEF-5), Chinese Index of Premature Ejaculation (CIPE-5), Intravaginal Ejaculatory Latency Time (IELT), and Sexual Satisfaction Score (SSS) were evaluated.

Both groups showed significant improvement in IIEF-5 scores, but the difference between groups was not significant (F = 0.89, p = 0.45). The active control group showed significant improvement in CIPE-5 scores (p < 0.001), while the experimental group showed no significant change (p > 0.05). IELT in the active control group increased significantly from 25.7 s to 198.6 s (Z = 6.03, p < 0.001), while the experimental group showed no significant change (Z = 0.74, p = 0.46). SSS improved significantly in the active control group (p < 0.001) but not in the experimental group (p > 0.05). The incidence of adverse events was similar in both groups (14% vs 20.8%, p = 0.575).

Tadalafil combined with lidocaine spray is superior to tadalafil alone in improving symptoms, prolonging IELT, and enhancing sexual satisfaction in patients with comorbid ED and PE, with comparable safety. This combination therapy provides a new approach for improving treatment strategies for patients with comorbid ED and PE. Large-scale, multi-center randomized controlled trials are needed to further validate these findings.