Abstract: PD69-02
Sources of Funding: PREBOOST &[reg] : Veru Healthcare / The Female Health Company

Introduction

Premature ejaculation (PE) is the most common form of sexual dysfunction in men yet few safe and effective therapies exist. A variety of local anesthetics have been studied, but lack of efficacy has restricted widespread use. We performed a randomized, double-blind controlled trial to evaluate the use of a novel topical 4% benzocaine wipe for management of PE.

Methods

We enrolled men aged ≥ 18 years in a heterosexual, monogamous relationship with PE as defined by self-reported poor control over ejaculation, personal distress related to ejaculation, and average intravaginal ejaculatory latency time (IELT) ≤ 2 minutes on stopwatch measurement. Subjects were randomized in a 2:1 fashion to treatment with benzocaine wipes or placebo. One month after randomization, men in the placebo group were crossed over to the treatment group. Primary outcome was change in IELT at two months. Secondary outcomes included change in questionnaire assessments including global rating of distress, medication assessment, and Index of Premature Ejaculation (IPE). Wilcoxon rank-sum test was used for comparison of all outcomes.

Results

An interim analysis was conducted in 21 men who were randomized (15 treatment, 6 placebo) and had complete follow-up data. Baseline mean ± standard deviation IELT was 74.3 ± 31.8 vs 84.9 ± 29.8 seconds among the treatment and placebo groups, respectively (p=0.39). After 2 months, men in the treatment group had significant improvement in IELT with a mean increase of 231.5 ± 166.9 seconds (95% confidence interval of 139-323 seconds) which was significantly greater than men on placebo (94.2 ± 67.1 seconds, p= 0.043). A greater proportion of men in the treatment group after one and two months achieved IELT of at least 2 minutes vs placebo (60%, 80.0% vs 33.3% respectively). Compared to placebo, men in the treatment group reported greater improvement in distress relating to intercourse, control of ejaculation, and satisfaction with sexual intercourse over the study period (p<0.01, p=0.01, and p<0.01, respectively). Treatment was well tolerated and no transference was reported.

Conclusions

Topical 4% benzocaine wipes improved both objective and subjective symptoms of PE compared to placebo.

Funding

PREBOOST &[reg] : Veru Healthcare / The Female Health Company