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Lidocaine Cream in Primary Premature Ejaculation

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Lidocaine Cream in Primary Premature Ejaculation International Journal of Impotence Research (2014) 26, 186–190 & 2014 Macmillan Publishers Limited All rights reserved 0955-9930/14 www.nature.com/ijir ORIGINAL ARTICLE A reassessment of penile sensory pathways and effects of prilocaine–lidocaine cream in primary premature ejaculation J-D Xia1, L-H Zhou2, Y-F Han1, Y Chen1,2, R Wang3 and Y-T Dai1,2 To assess the penile sensory pathway abnormalities of the patients with primary premature ejaculation (PPE) and effects of prilocaine–lidocaine (PLA) cream, we enrolled 82 PPE patients and 34 normal potent male volunteers. Somatosensory evoked potentials of dorsal nerve (DNSEP) and glans penis (GPSEP) were performed in each subject. In addition, among the 82 patients, 60 were selected and randomly divided into PLA and placebo subgroups, each with 30 patients. Cream was applied evenly on the glans penis for 10 min and washed off just before DNSEP and GPSEP were repeatedly measured. Mean latencies of DNSEP and GPSPE were both remarkably shorter in the patients than those in the normal potent men (Po0.001, both). Compared with the control group, the mean amplitudes of GPSEP were significantly greater in the patient group (Po0.001), but not considerably on the amplitudes of DNSEP (P ¼ 0.229). After cream application, the latencies and amplitudes of both DNSEP and GPSEP were significantly prolonged and reduced, respectively, in the PLA cream subgroup (Po0.001, all). These results showed that hyperexcitable ejaculatory reflex neurological factor was linked to PPE, because of hypersensitivity of the penile, accelerated conduction and cortical amplification of the genital stimuli. The PLA cream could delay sensory latency and decrease glans penile hyperexcitability, which may be the mechanism for PPE treatment. International Journal of Impotence Research (2014) 26, 186–190; doi:10.1038/ijir.2014.5; published online 27 February 2014 Keywords: local application; premature ejaculation; prilocaine-lidocaine; somatosensory evoked potentials INTRODUCTION stimuli7 and did not show correlation between penile sensitivity 8 Premature ejaculation (PE) is the most common male sexual and ejaculation latency time. Interestingly, with quantitative 9 dysfunction and affects 20–30% of the world’s male population.1 sensory testing analysis, Salonia et al. reported that the PPE There are several definitions of PE crafted by various professional patients had hyposensitivity, instead of hypersensitivity, profile. organizations or individuals. In 2008, the International Society of In the present study, we used somatosensory evoked potential Sexual Medicine developed the first contemporary multivariate (SEP) tests to reassess whether the PPE patients had penile evidence-based definition of the primary premature ejaculation sensory pathway abnormalities. (PPE): a male sexual dysfunction characterized by ejaculation that To date, there are no pharmacological agents approved for 10 always or nearly always occurs before or within about 1 min of use in PE, apart from dapoxetine in some European countries. vaginal penetration, and the inability to delay ejaculation on all or On the other hand, topical local anesthetics such as lidocaine and/ nearly all vaginal penetrations, and negative personal conse- or prilocaine, in the form of a cream, gel or spray, are moderately 11 quences, such as distress, bother, frustration and/or the avoidance effective in delaying ejaculation, although they were not of sexual intimacy.2 approved for the treatment of PE. To further evaluate the Clinically, PE is usually classified as either primary or acquired mechanism of local anesthetics in treating PPE, we conducted a depending on the time of onset of the problem in one’s life.3 randomized placebo-controlled study to observe the effects of Historically, it was thought that PE was caused by psycho- prilocaine–lidocaine (PLA) cream on latencies and amplitudes of logical and conditioning factors, such as unsolved unconscious SEPs in the patients with PPE. conflicts, interpersonal problems, inappropriate conditioning by early experiences or too low frequency of sex.4 Recently, opioid substance withdrawal, prostatic inflammation and hyper- MATERIALS AND METHODS thyroidism are considered to be the causes of acquired PE in Subjects some patients.5 On the other hand, studies have indicated that From October 2011 to January 2013, 82 patients with PPE attending to the somatic disorders and/or neurobiological imbalances constitute Department of Andrology of our hospital, and 34 voluntary, normal, the organic basis of PPE.5 It is considered that penile hyper- potent, adult men were enrolled in this study. Each subject had a stable sensitivity may be one of the pathologic mechanisms of PPE. The heterosexual partner for over 1 year. All the subjects signed informed consent, and the local ethics committee approved our investigations. results of a case–control study suggested that PPE patients had 6 PPE was determined based on the definition established by the hypersensitivity and hyperexcitability of the glans penis. How- International Society of Sexual Medicine,2 which is characterized by the ever, other investigations did not find either a faster conduction chronic inability to exert voluntary control over the ejaculatory reflex since or a greater cortical representation of the genital area sensory the beginning of sexual life, with the stopwatch intravaginal ejaculation 1Department of Andrology, Nanjing Drum Tower Hospital, Nanjing Medical University, Nanjing, China; 2Department of Andrology, The Affiliated Drum Tower Hospital of Nanjing University, School of Medicine, Nanjing, China and 3Department of Urology, University of Texas Medical School at Houston and M.D. Anderson Cancer Center, Houston, TX, USA. Correspondence: Dr Y-T Dai, Department of Andrology, Nanjing Drum Tower Hospital, Nanjing Medical University, Nanjing 210008, China. E-mail: [email protected] Received 27 April 2013; revised 9 December 2013; accepted 9 January 2014; published online 27 February 2014 Penile sensory pathways and effects of PLA in PPE J-d Xia et al 187 latency time (IELT) of fewer than 1 min. IELT was measured for the 4-week RESULTS baseline period during which all patients were asked to have sexual Subject characteristics intercourse at least four times. The normal potent men who presented satisfactory sexual intercourse and good control over ejaculation with the The median IELT of the 82 PPE patients was 38.9 s (27 of them average-estimated IELT more than 3 min were classified as the control within 30 s). Their PE symptoms lasted for 1–25 years, median 4.6 group. Neither normal subjects nor the patients had erectile dysfunction, years. Compared with the control group, the average CIPE-5 score genitourinary tract infection, systemic (diabetes, alcoholism, hyper- of the PPE group was significantly lower, indicating that the sexual tension, hyper- or hypo-thyroidism and others) or neurological disorders function of patients was highly worse than that of the normal and obvious psychological problems requiring psychiatric support or controls on ejaculation. However, there was no statistical continuous drug use that might alter sexual activities. Physical difference in marital status, age, height, body weight and IIEF-5 examinations, including the genitalia, were normal. To assist the score in both groups (Table 1). In addition, there was no diagnosis for the enrollment of PPE patients, we used The Chinese Index statistically significant difference in age, height, weight, CIPE-5 of PE, with five questions (CIPE-5) and International Index of Erectile Function-5 (IIEF-5).12,13 and IIEF-5 scores between the PLA and placebo cream application subgroups. Methods Comparison of SEPs latencies and amplitudes between the control An electromyograph and evoked potential equipment (Keypoint 4, Alpine and PPE groups BioMed ApS, Copenhagen, Denmark) was used to measure SEPs. SEPs M-shaped SEPs (DNSEP and GPSEP) were obtainable in both the consisted of dorsal nerve (DNSEP) and glans penis (GPSEP), with electrical normal subjects and the PPE patients. The typical GPSEP wave- stimuli on different places. DNSEP was performed as follows: the anode forms of the PPE patients and the controls are shown in Figure 1. ring was put on the subcoronal region and the cathode was placed on the shaft 2 cm proximal to the anode. The duration of stimuli was 1.0 ms and The Kolmogorov–Smirnov test showed that the latencies of SEPs the frequency was 3 s À 1. First, we detected the penile shaft sensory were normally distributed, but the amplitudes were abnormally threshold value, which was determined by gradually increasing from 0 mA distributed. The mean latencies of DNSEP and GPSEP were until the subject sensed tiny synchronous prickle stimulation. Subse- 39.33±4.62 ms and 41.48±3.53 ms, respectively, in the PPE quently, it was decreased step by step until the subject just could not feel group; and 43.24±2.15 ms and 44.57±1.78 ms in the control the stimulation. The decreasing intensity was considered as the critical group, respectively . Mean latencies of both DNSEP and GPSEP value. The same procedure was repeated 3 times, and all the critical values were significantly shorter in the PPE group than those in the were recorded and averaged to estimate the sensory threshold of the control group (Po0.001, both). In the two groups, the mean penile shaft. Following the determination of penile shaft sensory threshold, latencies of DNSEP were statistically shorter than those of GPSEP electrical stimuli were delivered to the penile shaft via ring electrodes with an intensity of three times that of the threshold value. In order to examine (Po0.001, 0.001, respectively). The median (interquartile range) whether there were differences in the cerebral response to the same values of DNSEP and GPSEP amplitudes were 1.32 (0.97–1.87) and intensity stimuli, we conducted GPSEP with a pair of round surface 1.87 (1.40–2.51) mV, respectively, in the PPE patients; and 1.22 electrodes placed at the glans penis and set the stimuli intensity at 10.0 mA (0.87–1.62) and 1.32 (1.01–1.64) mV, respectively, in the control (at this level, the subjects perceived no pain) in each subject.
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