RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF BENZOCAINE WIPES IN SUBJECTS WITH PREMATURE EJACULATION

Main Article Content

Ridwan Shabsigh
Michael A. Perelman
Robert H. Getzenberg
Allison Grant
Jed Kaminetsky

Keywords

benzocaine, premature ejaculation

Abstract

Aim
This study investigated the efficacy and safety of benzocaine wipes (PREBOOST) applied to the penis prior to intercourse for the treatment of men with premature ejaculation.
Materials and methods
The study utilized the local anesthetic benzocaine, in the form of wipes, for topical application to the glans penis prior to sexual intercourse. The design included three phases: screening and baseline, blinded randomized controlled, and an open-label phase with crossover of the placebo group to open-label active treatment. The two co-primary efficacy measures were the intravaginal ejaculatory latency time (IELT) measured by stopwatch, and the patient-reported outcome measured by the Index of Premature Ejaculation (IPE). Additional efficacy evaluation included a responder analysis using a predetermined 120s improvement in IELT as a responder threshold. Safety evaluation included patient-reported events along with a physical examination.


Results
The treatment phase showed a statistically significant increase from the baseline, in the treatment group (mean 165s) compared with the placebo group (mean 110s), P<0.007. After the second month of use, the treatment group had a mean IELT of 329.70s (±21.37 SE) in comparison to the placebo group which had a mean IELT of 110.10s (±9.90 SE) (P=0.001). The open-label phase showed further increase in IELT in the treatment group and a statistically significant increase in IELT in the placebo/ crossover group. Using the IPE, the men in the treatment group reported significantly higher sexual satisfaction (P=0.047) and greater improvement in distress (P=0.020) with a trend toward improve-ment in the ejaculatory control domain scores (P=0.093). The responder analysis showed a statisti-cally significant response to the use of benzocaine versus placebo, attesting an IELT increase that was clinically meaningful. Benzocaine wipes were well tolerated by subjects and partners.
Conclusion
This randomized, placebo controlled clinical trial with crossover design showed that benzocaine wipes applied topically to the penis prior to sexual intercourse had a statistically significant prolongation of time to ejaculation, a clinically meaningful benefit, in the treatment of premature ejaculation. Furthermore, benzocaine wipes were well tolerated by the subjects and no evidence of transference to their female partners.

Downloads

Download data is not yet available.
Abstract 696 | PDF Downloads 14565

References

1. Laumann EO, Paik A, Rosen C. Sexual dysfunc-tion in the United States: Prevalence and predic-tors. JAMA 1999;281:537.
2. American Psychiatric Association. Diagnostic & Statistical Manual of Mental Disorders. 4th ed. (DSM-IV). Washington, DC: American Psychiatric Association; 1994.
3. Vickers MA. The forgotten dysfunction: A phar-macological approach to premature ejaculation.In: Morales A, editor. Erectile dysfunction— Issues in current pharmacology. London: Martin Dunitz; 1998. p. 253.
4. Reading A, Weist W. An analysis of self-reported sexual behaviour in a sample of normal males. Arch Sex Behav 1984;13:69–83.
5. De Amicis LA, Goldberg DC, LoPiccolo J, Friedman J, Davies L. Clinical follow-up of cou-ples treated for sexual dysfunction. Arch Sex Behav 1985;14:467–89.
6. Beretta G, Chelo E, Fanciullacci F, Zanollo A. Effect of an alpha-blocking agent (phenoxyben-zamine) in the management of premature ejacula-tion. Acta Eur Fertil 1986;17:43–5.
7. Girgis SM, El-Haggar S, El-Hermouzy S. A dou-ble-blind trial of clomipramine in premature ejac-ulation. Andrologica 1982;14:364–8.
8. Kara H, Aydin S, Yucel M, Agargun MY, Odabas O, Yilmaz Y. The efficacy of fluoxetine in the treatment of premature ejaculation: A double-blind placebo controlled study. J Urol 1996;156: 1631–2.
9. McMahon CG. Treatment of premature ejacula-tion with sertraline hydrochloride. Int J Impot Res 1998;10:181–4.
10. McMahon CG, Touma K, Johnston H. Treatment of premature ejaculation with paroxetine hydro-chloride. Int J Impot Res 1998;10 (Suppl 3):S38.
11. Vignoli GC. Premature ejaculation: New electro-physiologic approach. Urology 1978;11:81–2.
12. Xin ZC, Chung WS, Choi YD, Seong DH, Choi YJ, Choi HK. Penile sensitivity in patients with primary premature ejaculation. J Urol 1996;156: 979–81.
13. Xin ZC, Choi YD, Rha KH, Choi HK. Somatosensory evoked potentials in patients with primary premature ejaculation. J Urol 1997;158: 451–5.
14. Althof S, Rosen R, Symonds T, Mundayat R, May K, Abraham L. Development and validation of a new questionnaire to assess sexual satisfac-tion, control, and distress associated with prema-ture ejaculation. J Sex Med 2006 May;3(3):465–75. PubMed PMID: 16681472