Lifelong Premature Ejaculation Research Articles

Is bulbospongiosus muscle botox injection safe and effective in treating lifelong premature ejaculation? Randomized controlled study

PurposeTo evaluate the safety and efficacy of botulinum-A toxin injections into the bulbospongiosus muscle for cases of lifelong drug-resistant premature ejaculation (PE).MethodsNinety-eight outpatients diagnosed with lifelong PE were randomly assigned to two groups: the botulinum-A toxin group comprising forty-nine patients and the placebo (saline) group also consisting of forty-nine patients. A 100 U botulinum-A toxin was diluted into 10 cc of saline, with 5 cc injected into one side of the muscle (botulinum-A toxin group) guided by ultrasound to distribute across most muscle fibers. The same technique was applied using the same volume of saline injected into the bulbospongiosus muscle. Intravaginal ejaculatory latency time (IELT), scores from the premature ejaculation profile (PEP), Premature Ejaculation Diagnostic Tool (PEDT), International Index of Erectile Function (IIEF), and recording of any complications were obtained. Follow-ups occurred at 1-, 3-, and 6-month post-procedure.ResultsCases receiving injections of botulinum-A toxin into the bulbospongiosus muscle showed notably extended intravaginal ejaculatory latency times compared to their initial performance after treatment. In addition, there were enhancements in PEP scores, and notably, no significant complications were reported. Conversely, the bilateral injection of saline into the bulbospongiosus muscle did not demonstrate any impact on ejaculation latencies.ConclusionOur study demonstrated that the injection of botulinum-A toxin into the bulbospongiosus muscle can serve as a safe and effective option for treating PE. Nonetheless, its clinical application warrants further studies involving larger sample sizes and longer follow-up periods.

(067) The Outcome of Bulbospongiosus Muscle Injection with Botulinum-A Toxin for Treatment of Lifelong Premature Ejaculation; A Randomized Controlled Trial

Abstract Introduction Lifelong premature ejaculation (PE) is considered one of the commonest sexual disorder affecting men with an estimated prevalence of 2–5%. [1,2] Many definitions have been proposed for lifelong PE, the most accepted is the ISSM’s which consider PE “ejaculation which always or nearly always occurs prior to or within about 1 minute of vaginal penetration from first sexual experiences (lifelong premature ejaculation) + Negative personal consequences such as distress, bother, frustration, and/or the avoidance of sexual intimacy”.[3] However, there is no doubt that lifelong PE negatively affects the quality of life of the patient and his partner. [2] Proper assessment of this problem in an objective validated way has always been a challenge. [4] Treatment also varied from behavioral techniques, SSRIs and local anaesthetics with very variable outcome, unsatisfactory for many patients. [5] New lines have been always evolving trying to address this resistant category of patients such as injection of the glans penis with filler [6] or neurectomy of the dorsal nerve of the penis. [7] Herein; we assess a new line of treatment for lifelong PE which theoretically can inhibit the stereotyped rhythmic contractions of the bulbospongiosus muscle during the reflex of ejaculation using botulinum-A toxin; in a prospective, randomized, placebo-controlled study. Objective This study aimed to assess a new line of treatment for lifelong premature ejaculation (PE) which is botulinum-A toxin injection into the bulbospongiosus muscle. Methods It was conducted at the Andrology Unit of Tanta University in Egypt between November 2020 and November 2022. Patients with lifelong PE were considered for this study. Those suffering from PE secondary to erectile dysfunction, genital infection or psychic stress were excluded. Patients have been asked to stop any medical treatment that could affect their sexual function eg PDE5i and medications for lifelong PE; for at least 1 month before injection as well as 6 months thereafter. Sixty patients with lifelong PE have been prospectively enrolled and randomized into 2 groups; the test group (group A) was injected with 100 U botulinum-A toxin at 10 U/ml and the control group (group B) which was injected with the same volume of saline into the bulbospongiosus muscle. Injection was done in lithotomy position, using a fanning technique, under US guidance using the superficial probe to localize the site of injection. Fifty-seven patients of 60 completed the follow up protocol. Results Fifty-seven patients of 60 completed the follow up protocol. The IELT, PEP score and female satisfaction showed no statistically significant difference between both groups at the 1, 3 and 6 months post intervention. However, in the treatment group, the median (IQR) PEP score increased significantly after 1 and 3 months with a mean difference of 1.6 and 95 % CI of (0.7–2.5), P=0.001 and 0.9 and 95% CI of (1.07–1.69), P=0.02 respectively. Whereas insignificant change was noted at 6 months, with a mean difference of 0.13.In the control group however, there was no significant change of any of the tested parameters at any the 3 time points. Adverse reactions were minor and observed only in 3 cases (5%). Conclusions botulinum A injection into the BS muscle seems to be safe, but failed to prove efficacy when compared to placebo in treatment of lifelong PE Disclosure No.

(259) Comparison of Dapoxetine vs Paroxetine vs Clomipramine for Premature Ejaculation Patients

Abstract Introduction Premature ejaculation (PE) is a common male sexual dysfunction. The International Society for Sexual Medicine (ISSM) defines PE as the inability to delay ejaculation during all or nearly all vaginal penetrations with latency time before or within 1 minute of penetration for lifelong PE and within 3 minutes for acquired PE and negative personal consequences such as distress, bother, frustration. The introduction of Selective Serotonin reuptake inhibitors (SSRIs) and Tricyclic antidepressants (TCA) revolutionized the treatment of PE. However not many studies have compared the efficacy and safety of these drugs in a single study. Objective To compare the clinical efficacy and safety of Dapoxetine, Paroxetine, and Clomipramine for the oral pharmacotherapy of PE. Methods Men presenting with self-reported PE were evaluated with full medical/sexual history, comorbidities, focused physical examination, assessment for Erectile function, any investigations suggested by these findings. IELT was determined by stopwatch method for every intercourse attempt. IELT were recorded before and after using the above medications in each group. ISSM definition of PE formed basis of diagnosis. All patients were married potent men in a stable relationship for at least 6 months and possible sexual intercourse equal or greater than one per week. None of the patients had received other treatment for PE for at least 4 weeks before the start of the study. All subjects gave their written informed consent before entering the study. Standardized assessment measures such as validated questionnaires & Patient Reported Outcomes (PRO) used as adjunct for assessment. Results 48 Patients with PE were recruited in this study. Patients were randomly assigned to receive 60 mg Dapoxetine ‘on-demand’(group 1, n = 24), or 20 mg Paroxetine daily (group 2, n = 12) or 50 mg Clomipramine (group 3, n = 12) orally daily during a 12-week period for each agent. After 12 weeks of treatment with Dapoxetine, Paroxetine and Clomipramine, the IELT was increased from the pretreatment mean of 35 seconds to 184 seconds, from 32 seconds to 178 seconds and from 34 seconds to 169 seconds, respectively (P = 0.01 in group 1 and 2,P = 0.02 in group 3). Baseline and 12-week mean intercourse satisfaction domain values of the IIEF were 10, 11, 10 and 14, 15, 13 in groups 1, 2, and 3 respectively. The mean number of coitus per week pretreatment and at 12-week treatment were 1.4, 1.3 and 1.3/week which rose to 2.4, 2.3 and 2.2 for Dapoxetine, Paroxetine and Clomipramine, respectively. The most common adverse effects of each drug were nausea, diarrhea, headache and perspiration. Conclusions Oral SSRIs & TCA are safe and effective treatments for PE. Dapoxetine, although approved, does Not appear to be widely used; cost could be an issue. Its use can result in better QoL for the patient and their sexual partner. Paroxetine has the advantage of improving IELT with well-tolerated side effects. It has good efficacy in the treatment of PE. Higher dose of Clomipramine results in a longer IELT without higher risk of adverse events. Larger studies with different dosages and treatment regimens are required to yield more credible outcomes. Disclosure No.

Effect of bulbospongiosus muscle injection with botulinum-A toxin for treatment of lifelong premature ejaculation; a randomized controlled trial.

This study aimed at assessing a new line of treatment for lifelong premature ejaculation which is botulinum-A toxin injection into the bulbospongiosus muscle. Sixty patients with lifelong premature ejaculation were independently randomized into 2 groups; group I, 100 U botulinum-A toxin at 10 U/ml saline was injected with ultrasound guidance into the bulbospongiosus muscle and group II which was injected with similar volume of saline. The primary outcome was to compare both groups for changes in the Premature Ejaculation Profile (PEP), Intravaginal Ejaculatory Latency Time (IELT) and partner's satisfaction at 1, 3 and 6 months after intervention. The second outcome was to compare the adverse events in both groups. Fifty-seven patients completed the study. In group I, the mean PEP increased significantly at 1- (P = 0.02) and 3- months (P = 0.04) with insignificant increase at 6-month (P = 0.6) of follow-up. Also, no significant changes had been noted in IELT or partner's satisfaction scores throughout the study duration (P > 0.05). In group II, no significant changes had been noted in the PEP, IELT and partner's satisfaction scores throughout the study duration (P > 0.05). There were insignificant differences in the changes in the mean PEP (P = 0.7, 0.6 and 0.4), IELT (P = 0.6,0.6 and 0.5) and partner's satisfaction scores (P = 0.5,0.7 and 0.3) in comparison to the baseline values at 1-, 3- and 6- months, respectively between both groups. Adverse events were observed in only 3 patients (5.3%). In group I, mild erectile dysfunction and post micturition dribbling were reported in one patient each. Where in group II, one patient reported bleeding per urethra (P = 0.5). To conclude, injection of botulinum-A toxin into bulbospongiosus seems to be safe but failed to prove clinical efficacy for treatment of lifelong premature ejaculation when compared to placebo.

The association of reproductive hormones, thyroid function, and vitamin levels with premature ejaculation: A prospective case-control study.

To investigate whether serum hormone (testosterone, prolactin, gonadotropins, and thyroid hormones) and vitamin (vitamin B12, folic acid, and vitamin D) levels are associated with premature ejaculation (PE). This prospective case-control study included 126 patients with PE (lifelong PE [LPE] in 94 and acquired PE [APE] in 32) who presented to the urology outpatient clinic between April 2016 and January 2023 and 92 healthy men as a control group. The diagnosis of PE was based on the criteria defined by the International Society for Sexual Medicine. Serum total testosterone (TT), free and bioavailable testosterone, follicle-stimulating hormone, luteinizing hormone, prolactin, thyroid-stimulating hormone, free triiodothyronine, thyroxine (fT4), vitamin B12, folic acid, and vitamin D levels were measured. Serum TT, fT4, and vitamin D levels were significantly higher in patients with PE than in the control group (p=0.022, p=0.002, and p=0.044, respectively). However, the serum vitamin B12 level was significantly lower in the PE group (p=0.021). In the multivariate logistic regression analysis, only vitamin B12 was found to be an independent risk factor for PE, with an estimated odds ratio of 0.997 (95% confidence interval 0.994-0.999, p=0.036). This study demonstrated that lower vitamin B12 levels are associated with the presence of PE. Therefore, we believe that it would be beneficial to consider vitamin B12 levels in the evaluation of patients with PE.

Daily intake of 30 mg duloxetine is effective in decreasing premature ejaculation severity: a prospective randomized placebo-controlled cross over clinical trial

BackgroundPremature ejaculation (PE) is considered to be the most common male sexual disorder affecting 20% to 66% of sexually active men. Most of the patients had already tried on demand dapoxitine with no improvement. We aimed in the current study to assert the efficacy and safety profile of daily intake of 30 mg duloxetine in treating patients with lifelong premature ejaculation (LPE) as well as patients with acquired premature ejaculation (APE).ResultsThe current study showed significant improvement in intravaginal ejaculatory latency time (IELT) after intake of duloxetine. All participants had a median Arabic index of premature ejaculation (AIPE) of 26, median IELT of 180 s, median male sexual quality of life (SQOL) of 43 after being treated with duloxetine (p value < 0.001 for all). While median AIPE after placebo was 19, median IELT after placebo was 60 s and median male SQOL after placebo was 21. Paired comparison of AIPE, IELT (Secs), inter quartile range (IQR) and male SQOL in group (A) patients at baseline and after duloxetine intake showed statistically significant improvement among treated patients (p values < 0.001 for all). Paired comparison of AIPE, IELT (Secs), IQR and male SQOL in group (A) patients at baseline and after placebo treatment showed no significant improvement of male SQOL. Furthermore, AIPE and IELT returned to baseline scores after discontinuation of duloxetine (p values 0.729; 0.892, respectively). Paired comparison of AIPE, IELT (Secs), IQR and male SQOL in group (B) patients at baseline and after placebo treatment showed almost same scores of patients in group (A) who received placebo for 2 months after a 2 month washout period (p values 1.000 for all).Paired comparison of AIPE, IELT (Secs), IQR and male SQOL in group (B) patients at baseline and after duloxetine treatment showed statistically significant improvement among all treated patients (p values < 0.001 for all).ConclusionDuloxetine is an effective drug for treatment of LPE and APE patients. Further, larger studies are needed to compare duloxetine to different known therapeutic modalities for PE to assert it’s efficacy and superiority.

Regular penis-root masturbation: A promising behavioral treatment method for lifelong premature ejaculation.

We aimed to determine the effectiveness of penis-root masturbation (PRM), a newly defined behavioral therapy (BT) technique, in patients with unsuccessful medical treatment due to premature ejaculation (PE). The study included 35 patients aged 25-43 years, who were diagnosed with lifelong PE. Patients and their partners were informed about the PRM technique and asked to practice PRM three times a week for three months, with or without sexual intercourse. The patients' Premature Ejaculation Diagnostic Tool (PEDT) scores and intravaginal ejaculatory latency time (IELT) were recorded and compared before PRM training (T0) and at the third (T3) month after the start of PRM training. The mean±SD PEDT scores were 16.26±1.94 at T0, 10.63±1.14 at T3. When compared to T0, the PEDT values at T3 were significantly lower (P=0.021). In terms of IELT, the mean T3 values (192.43±56.71) were significantly longer (P=0.035) than at T0 (50.43±13.84seconds). PRM BT shows promise for lifelong PE patients who do not benefit from or discontinue to pharmacotherapy. Larger prospective trials are required to confirm these findings.

Do Ejaculation Latency and Other Sexual Measures Differ Between Men With Lifelong and Acquired Premature Ejaculation?

To determine whether men with lifelong vs acquired premature ejaculation (PE) subtypes differ on their estimated ejaculation latencies (EL) and related sexual, relationship, and behavioral parameters. Of 2679 men who responded to an online multinational survey about sexual health and met inclusion criteria, 540 reported "probable" or "definite" PE, as assessed by the Premature Ejaculation Diagnostic Tool. Lifelong and acquired PE subtypes were compared on multiple measures related to EL, as well as on sets of demographic, diagnostic, relationship, sexual behavioral, and sexual functioning measures during both partnered sex and masturbation. Nearly 73% of men with PE in this sample reported the lifelong subtype. No differences emerged in EL measures between subtypes, even when parsed according to age. Specifically, men 37years or under with either definite lifelong or acquired PE reported ELs of 1.9 minutes (SD=1.3). For men over 37, lifelong ELs were 2.0 minutes (SD=1.3), acquired ELs 2.4 minutes (SD=1.4). While the lifelong subgroup was younger and reported lower erectile functioning, these differences occurred only in the probable PE group and not the definite PE group. Our data do not support different EL criteria for men with acquired vs lifelong PE, as suggested by several professional definitions. Furthermore, differences in age and erectile functioning between the groups, often reported in clinical samples though not in our definite PE group, may be an artifact of the general health/patient characteristics that lead such men to seek medical assistance.

Decreased grey matter volume in dorsolateral prefrontal cortex and thalamus accompanied by compensatory increases in middle cingulate gyrus of premature ejaculation patients.

The prefrontal-cingulate-thalamic areas are associated with ejaculation control. Functionalabnormalities of these areas and decreased grey matter volume (GMV) in the subcortical areas have been confirmed in premature ejaculation (PE) patients. However, no study has explored the corresponding GMVchanges in the prefrontal-cingulate-thalamic areas, which are considered as the important basis for functionalabnormalities. This study aimed to investigated whether PE patients exhibited impaired GMV in the brain, especially the prefrontal-cingulate-thalamic areas, and whether these structural deficits were associated with declined ejaculatory control. T1-weighted structural magnetic resonance imaging (MRI) data were acquired from 50 lifelong PE patients and 50 age-, and education-matched healthy controls (HCs). The PE diagnostic tool (PEDT) was applied to assess the subjective symptoms of PE. Based on the method of voxel-based morphometry (VBM), GMV were measured and compared between groups. In addition, the correlations between GMV of brain regions showed differences between groups and PEDT scores were evaluated in the patient group. PE patients showed decreased GMV in the right dorsolateral superior frontal gyrus (clusters=13, peak T-values=-4.30) and left thalamus (clusters=47, T=-4.33), and increased GMV in the left middle cingulate gyrus (clusters=12, T=4.02) when compared with HCs. In the patient group, GMV of the left thalamus were negatively associated with PEDT scores (r=-0.35; P=0.01). Receiver operating characteristic (ROC) analysis showed that GMV of the right dorsolateral superior frontal gyrus (AUC=0.71, P<0.01, sensitivity=60%, specificity=78%), left thalamus (AUC=0.72, P<0.01, sensitivity=92%, specificity=46%) and middle cingulate gyrus (AUC=0.69, P<0.01, sensitivity=50%, specificity=90%), and the combined model (AUC=0.84, P<0.01, sensitivity=78%, specificity=80%) all had theability to distinguish PE patients from HCs. Disturbances in GMV were revealed in the prefrontal-cingulate-thalamic areas of PE patients. The findings implied that decreased GMV in the dorsolateral prefrontal cortex and thalamus might be associated with the central pathological neural mechanism underlying the declined ejaculatory control while increased GMV in the middle cingulate gyrus might be the compensatory mechanism underlying PE.

A new approach to 'on-demand' treatment of lifelong premature ejaculation by treatment with a combination of a 5-HT1A receptor antagonist and SSRI in rats.

Lifelong premature ejaculation (PE) in men lacks an adequate on-demand pharmacological treatment. Although selective serotonin reuptake inhibitors (SSRIs) are used for PE they only work after chronic treatment, or if used on-demand, less adequately than chronic SSRI treatment. It has been shown that the addition of a behaviorally silent 5-HT1A-receptor antagonist to an SSRI can generate acute inhibitory effects on male rat sexual behavior. Atlas987 is a selective 5-HT1A-receptor antagonist with equal potency to displace agonist and antagonist binding to pre- and post-synaptic 5-HT1A receptors in rat and human brain. To investigate whether Atlas987 together with the SSRI paroxetine, a combination called Enduro, induces acute inhibitory effects on male rat sexual behavior, we tested Enduro in Wistar rats in a dose-dependent manner. We first tested the 5-HT1A receptor antagonist Atlas987 in 8-OH-DPAT induced serotonergic behavior in rats. Second, we tested Enduro in a dose-dependent manner in male sexual behavior. Third, we tested the effective time window of Enduro's action, and lastly, we measured the plasma levels of Atlas987 and paroxetine over an 8-h period. Results showed that Enduro acutely and dose-dependently reduced the number of ejaculations and increased the ejaculation latencies. The behavioral pattern induced reflected a specific effect on sexual behavior excluding non-specific effects like sedation or sensoric-motoric disturbances. The time-window of activity of Enduro showed that this sexual inhibitory activity was at least found in a 1-4 h' time window after administration. Plasma levels showed that in this time frame both Atlas987 and paroxetine are present. In conclusion, in rats, Enduro is successful in acutely inhibiting sexual behavior. These results may be therapeutically attractive as "on demand" treatment for life-long premature ejaculation in men.

Dapoxetine versus glans penis injection with hyaluronic acid gel in treatment of premature ejaculation

ABSTRACT Objective to compare the results of using Dapoxetine and HA (hyaluronic acid) gel injection by Five puncture technique in the treatment of premature ejaculation (PE). Methods 100 sexually active heterosexuals circumcised males with lifelong PE were included in the study. Group A patients were treated with on-demand Dapoxetine, while group B was treated with HA gel glans penis injection using a five-puncture technique. Both groups were evaluated at 1st,3rd and 6th months post-treatment using IELT. Results There were no significant differences between both groups regarding patient demographic. Mean pretreatment IELT in groups A and B were 45.82 ± 7.44 and 46.18 ± 7.82 receptively. There was no significant difference between both groups. After treatment, both groups show significant ILET improvement during the 1st,3rd, and 6th months follow-up with a P value < 0.001. However, when comparing the improvement of ILET in group A (Dapoxetine) and group B (HA injection), there were high significance differences in favor of group B in the 1st,3rd, and 6th-month follow-up. Conclusion Although both treatment modalities have improved IELT and premature ejaculation, but HA injection with five punctures technique was significantly better than oral Dapoxetine with self-limited side effects.

Efficacy and Safety of Combination Therapy with Tadalafil and Sertraline for Premature Ejaculation: A Double-blind Randomized Controlled Trial

Background and Objective: Selective serotonin reuptake inhibitors (SSRIs) are effective in patients with premature ejaculation (PE), but the effect of combination therapy with tadalafil as a phosphodiesterase-5 inhibitor (PDE5I) and sertraline (an SSRI) in these patients has been less studied. The aim of this study was to evaluate the safety and efficacy of tadalafil with sertraline compared with sertraline and placebo. Materials and Methods: 107 patients with lifelong PE and no erectile dysfunction (ED) and an intravaginal ejaculation latency time (IELT) of less than 60s were treated for 6 weeks. Subjects were randomly divided into two groups: the placebo group (n=51) and the tadalafil group (n=51), who received sertraline 50 mg daily plus placebo on demand or sertraline 50 mg daily plus tadalafil 10 mg on demand . Premature ejaculation profile (PEP) and IELT were used to evaluate PE. The change in mean IELT, mean change in all four measures of PEP, and adverse effects in 2 groups were recorded. Results: Mean IELT before and after treatment was 35 .29sand 87 .55s, respectively, in the placebo group (P&lt;0 ,0001) and 40 .1s and 153.63s, respectively, in the tadalafil group (P&lt;0 .0001). Mean IELT improved significantly in the tadalafil group compared with the placebo group (113.53s vs. 52.25s, P&lt;0.0001). All four measures of PEP scores also improved in the tadalafil group compared with the placebo group. Drug-related adverse events occurred more frequently in group B than in group A. Conclusion: Combination therapy with tadalafil and sertraline in the treatment of premature ejaculation is more effective than sertraline alone despite more side effects.

(182) The Differences in Brain Function Between Lifelong Premature Ejaculation and Delayed Ejaculation: A Study Based on High-density Electroencephalogram

Abstract Introduction Ejaculatory dysfunction is common male sexual dysfunction, which is a conceptual continuum, and premature ejaculation (PE) and delayed ejaculation (DE) anchor the opposite ends of this conceptual continuum, and normal ejaculation is in the center. The pathogenesis of PE and DE is still not fully elucidated, and the studies on the central nervous mechanisms are highly lacking, and the differences in brain function between PE and DE are unclear. Objective We try to use a high-density electroencephalogram (HDEEG) to explore the differences in brain function to compensate for the deficiency of previous studies based on functional magnetic resonance Imaging (fMRI) and provide a theoretical foundation for future studies exploring the treatment methods. Methods We included 12 lifelong premature ejaculation (LPE) patients and 11 lifelong delayed ejaculation (LDE) patients, and all of them are right-handed. We evaluated the conditions of all subjects, who reported estimated intravaginal ejaculation latency time (eIELT). We used the premature ejaculation diagnostic tool (PEDT), the abridged international index of erectile function (IIEF-6), and erection hardness score (EHS) to quantify the sexual function and sexual arousal. EEG signals were recorded in patients with LDE and LPE during two segments of resting and watching an erotic video, respectively. The duration of the recording was about five minutes and fifteen minutes, respectively. The subjects whose EEG signals were less than 30 segments were excluded from the final analysis. The power spectral density was analyzed based on fast Fourier transform (FFT). Differences in the power spectral density during resting and sexual arousal between the two groups were compared. We analyzed changes in the power spectral density of β oscillation with sexual arousal in each group. Results There were no statistical differences in the general clinical characteristics. The mean eIELT of LPE patients was 0.8 ± 0.4 minutes. The scores of EHS were not statistically different during watching an erotic video between the two groups. There were no significant differences in δ, θ, and α oscillations between the LDE group and the LPE group during resting, but the LDE group had significantly higher power of β1, β2, and β3 oscillations. The power of β1, β2, and β3 oscillations was significantly higher in the LDE group during watching an erotic video, and other oscillations were not significantly different. The power of β1, β2, and β3 oscillations significantly increased in the LDE group during sexual arousal, and β2 and β3 oscillations significantly increased in the LPE group. Conclusions Based on the previous literature and our results, we proposed a scientific hypothesis to explain the increase of β oscillation in LDE patients. The increase of β oscillation is associated with the activation of the inhibitory brain area. The over-activation of the inhibitory brain area leads to LDE and the under-activation leads to LPE. The activation of the inhibitory brain area may be associated with gamma-aminobutyric, which is an inhibitory neurotransmitter. Disclosure No

(184) A Novel, On-demand Therapy for Lifelong Premature Ejaculation using a Miniature Trans-Perineal Electrical Stimulator, the vPatch - a Randomized Controlled Trial

Abstract Introduction While Premature Ejaculation (PE) is a common and disturbing sexual dysfunction in men, currently available treatment modalities have limited efficacy and low treatment adherence. In this study, we assessed perineal Transcutaneous Electrical Stimulation (TES) as a new possibility to treat (PE) Objective To assess the feasibility, safety, and efficacy of vPatch, a miniaturized on-demand perineal (TES) device, for treating PE. Methods We designed a bi-center, international, prospective, randomized, double-blind, two-arm, sham-controlled, first-in-human, clinical study. Calculating for statistical power, 59 patients 21-56 (mean 39.8+9.28) y/o with lifelong PE were included. During the initial visit, intravaginal ejaculatory latency time (IELT) was measured over a 2-week run-in period. Eligibility was confirmed in Visit 2, based on IELT values, and medical/sexual history. Eligible patients tried the vPatch to determine the individualized sensory and motor activation thresholds. Patients were randomized to Active (vPatch) and Sham device groups in a 2:1 ratio. During Visit 3, IELTs, Clinical Global Impression of Change (CGIC) scores, and Premature Ejaculation Profile (PEP) questionnaire outcomes were recorded. The vPatch device safety profile was determined by comparing the incidence of treatment-emergent adverse events. Primary endpoints assessed: 1. vPatch device efficacy as mean fold change in geometric mean IELT; each person was compared to themselves, with and without the device, and the Sham group was compared to the Active Group. 2. vPatch safety profile. Secondary endpoints assessed changes in (PEP) before and after treatment and last visit (CGIC) scores. Results Of 59 patients, 51 completed the study, 34 in Active and 17 in Sham Group. The baseline geometric mean IELT significantly increased from 67 to 123 seconds (p&amp;lt;0.0001) in the Active Group, as compared to increasing insignificantly from 63 to 81 seconds (p=0.1653) in the Sham Group. IELT significantly increased by 3.22-fold in the Active as compared to the Sham group (p=0.0047). Geometric mean time fold increases of IELT in Active compared to the Sham group were 1.7 (95% CI 1.5-2.1) vs. 1.2 (95% CI 1.0-1.6), respectively. No serious adverse events were reported. According to the CGIC, patients in the active group were significantly more satisfied with the treatment (74% vs. 41%, p=0.0274). The subjects in the active arm reported significant improvement in all 4 PEP parameters (P&amp;lt;0.05). Conclusions We demonstrated the possibility to treat lifelong PE by prolonging coitus on-demand, using electric stimulation of ejaculation muscles with vPatch. This treatment may potentially become an on-demand, non-invasive, and drug-free treatment for PE. Disclosure Yes, this is sponsored by industry/sponsor: Virility LTD, Israel Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Virility LTD, Israel.

46 - Long term follow-up outcomes of pelvic floor rehabilitation in subjects suffering from lifelong premature ejaculation: Retrospective multicentre study

46 - Long term follow-up outcomes of pelvic floor rehabilitation in subjects suffering from lifelong premature ejaculation: Retrospective multicentre study

Influence of TPH2 and HTR1A polymorphisms on lifelong premature ejaculation risk among the chinese Han population

BackgroundLifelong premature ejaculation (LPE) is one of the most common ejaculatory dysfunctions in men. The serotonin (5-HT) synthesis rate-limiting enzyme (TPH2) and receptor (HTR1A) in the 5-HT regulatory system may play a key role in the pathogenesis of LPE. However, there are few studies on the effects of TPH2 and HTR1A polymorphisms on LPE risk. We speculated that TPH2 and HTR1A polymorphisms may affect the occurrence and development of LPE in the Chinese Han population.MethodsIn this study, 91 patients with LPE and 362 normal controls aged 18 to 64 years were enrolled in the male urology department of Hainan General Hospital in China from January 2016 to December 2018. The SNPs in HTR1A and TPH2, which are related to 5-HT regulation, were selected as indexes to genotype the collected blood samples of participants. Logistic regression was used to analyze the correlation between SNPs of HTR1A and TPH2 with LPE susceptibility, as well as the relationship with leptin, 5-HT and folic acid levels.ResultsThe results revealed that HTR1A-rs6295 increased LPE risk in recessive model. Rs11178996 in TPH2 significantly reduced susceptibility to LPE in allelic (odds ratio (OR) = 0.68, 95% confidence interval (95% CI) = 0.49–0.96, p = 0.027), codominant (OR = 0.58, 95% CI = 0.35–0.98, p = 0.040), dominant (OR = 0.58, 95% CI = 0.36–0.92, p = 0.020), and additive (OR = 0.71, 95% CI = 0.52–0.98, p = 0.039) models. Grs11179041Trs10879352 could reduce the risk of LPE (OR = 0.44, 95% CI = 0.22–0.90, p = 0.024) by haplotype analysis.ConclusionHTR1A-rs6295 and TPH2-rs11178996 are associated with LPE risk in the Chinese Han population based on the finding of this study.

PD11-06 LONG TERM FOLLOW-UP OUTCOMES OF PELVIC FLOOR REHABILITATION IN SUBJECTS SUFFERING FROM LIFELONG PREMATURE EJACULATION: RETROSPECTIVE MULTICENTRE STUDY

You have accessJournal of UrologyCME1 Apr 2023PD11-06 LONG TERM FOLLOW-UP OUTCOMES OF PELVIC FLOOR REHABILITATION IN SUBJECTS SUFFERING FROM LIFELONG PREMATURE EJACULATION: RETROSPECTIVE MULTICENTRE STUDY Antonio Luigi Pastore, Yazan Al Salhi, Andrea Fuschi, Alessia Martoccia, Fabio Maria Valenzi, Alessandro Sciarra, Stefano Salciccia, de Nunzio Cosimo, Andrea Tubaro, Costantino Leonardo, Giorgio Franco, and Antonio Carbone Antonio Luigi PastoreAntonio Luigi Pastore More articles by this author , Yazan Al SalhiYazan Al Salhi More articles by this author , Andrea FuschiAndrea Fuschi More articles by this author , Alessia MartocciaAlessia Martoccia More articles by this author , Fabio Maria ValenziFabio Maria Valenzi More articles by this author , Alessandro SciarraAlessandro Sciarra More articles by this author , Stefano SalcicciaStefano Salciccia More articles by this author , de Nunzio Cosimode Nunzio Cosimo More articles by this author , Andrea TubaroAndrea Tubaro More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Giorgio FrancoGiorgio Franco More articles by this author , and Antonio CarboneAntonio Carbone More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003251.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The aim of the study is to investigate the long-term follow-up outcomes of pelvic floor muscle (PFM) rehabilitation in males suffering from lifelong premature ejaculation (LPE). To evaluate LPE, patients were investigated with intravaginal ejaculatory latency time (IELT) and the self-report Premature Ejaculation Diagnostic Tool (PEDT). These two collected data represented the primary outcome endpoints. METHODS: This retrospective study evaluated 227 subjects with LPE diagnosis, and a total of 171 pts out of 227 (75%) completed the training protocol and at least the follow-up of 72 months. At baseline, all participants reported an IELT ≤60 s and PEDT score >11. Participants completed a 12-week program of PFM rehabilitation, including physio-kinesiotherapy treatment, electrostimulation, and biofeedback, with three sessions per week, with 20 min for each component completed at each session. The effectiveness of intervention was evaluated by comparing the geometric means of IELT times and PEDT scores observed from baseline, to 6, and 12 months during the intervention, and at 24, 36, 48, 60 and 72 months postintervention, using a paired sample 2-tailed t-test, including the associated 95% confidence intervals. RESULTS: One hundred seventy-one participants completed the PFM rehabilitation protocol with 36 sessions of PFM. All subjects achieved the control of ejaculation reflex, reporting a mean IELT of 181.4 s and PEDT score of 2.5 at the 12-week endpoint of the intervention, representing an increase from baseline of 54.9 s and 16.6 scores, respectively, for IELT and PEDT (p < 0.0001). Of the 171 participants who completed the 60-month follow-up, 80%, 78%, 74%, 69 and 67% reported a satisfactory ejaculation control maintenance through the follow-up evaluations at 24, 36, 48, 60 and 72 months after completing PFM rehabilitation, respectively. CONCLUSIONS: Our study is the first on LPE treatment with such long-term follow-up (6 years). The results observed are statistically significant and support a role of PFM as an effective and safe therapy in LPE subjects. A prospective randomized study is requested to assess the role of PFM in PE. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e334 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Antonio Luigi Pastore More articles by this author Yazan Al Salhi More articles by this author Andrea Fuschi More articles by this author Alessia Martoccia More articles by this author Fabio Maria Valenzi More articles by this author Alessandro Sciarra More articles by this author Stefano Salciccia More articles by this author de Nunzio Cosimo More articles by this author Andrea Tubaro More articles by this author Costantino Leonardo More articles by this author Giorgio Franco More articles by this author Antonio Carbone More articles by this author Expand All Advertisement PDF downloadLoading ...

MP79-06 COMPLIANCE OF DAPOXETINE IN PATIENTS WITH PREMATURE EJACULATION: A 2-YEAR PROSPECTIVE OBSERVATIONAL STUDY

You have accessJournal of UrologyCME1 Apr 2023MP79-06 COMPLIANCE OF DAPOXETINE IN PATIENTS WITH PREMATURE EJACULATION: A 2-YEAR PROSPECTIVE OBSERVATIONAL STUDY Hyun Jun Park Hyun Jun ParkHyun Jun Park More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although dapoxetine is the only oral pharmacological agent approved for the treatment of premature ejaculation (PE), and is very effective, the discontinuation rate is high. We assessed the discontinuation rate in patients with PE, and the reasons for discontinuation, in real-world practice. METHODS: A total of 182 consecutive patients were enrolled. The type of PE, the self-estimated intravaginal ejaculation latency time (IELT), and medical history were evaluated in all patients, who also completed the International Index of Erectile Function-Erectile Function Domain (IIEF-EFD) questionnaire. Visits were scheduled 1, 3, 6, 12, and 24 months after initiation of therapy; we checked treatment status and the reasons for discontinuation in those who did in fact discontinue. We compared the relationships of discontinuation rates with various parameters and the time to discontinuation after treatment commencement. RESULTS: Of all patients, 9.9% continued treatment to 2 years. The cumulative discontinuation rates at 1, 3, 6, 12, and 24 months were 26.4%, 61.6%, 79.1%, 87.3%, and 90.1%, respectively. 79.1% of all patients discontinued treatment within 6 months. After 12 months, however, the discontinuation rate fell sharply. The reasons for discontinuation were cost (29.9%), disappointment that PE was not curable and that dapoxetine was required every time sexual intercourse was contemplated (25%), side effects (11.6%), perceived poor efficacy (9.8%), a search for other treatment options (5.5%), and unknown (18.3%). Patients with acquired PE (compared to lifelong PE), with IELT >2 min prior to treatment, on PDE-5 inhibitors, and with IIEF-EF scores <26 tended to discontinue early and thus exhibited high drop-out rates. CONCLUSIONS: The treatment discontinuation rate of dapoxetine was very high. The main reasons for discontinuation were the cost and disappointment that treatment was required every time adequate sexual function was required. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1143 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hyun Jun Park More articles by this author Expand All Advertisement PDF downloadLoading ...

Possible Pathophysiological Roles of Neurotransmitter Systems in Men With Lifelong Premature Ejaculation: Protocol for a Scoping Review

Lifelong premature ejaculation (LPE) is a rare sexual condition believed to be caused by genetic neurobiological disorders. In the field of LPE, 2 main types of research have been conducted: direct genetic research and pharmacotherapeutic interference of neurotransmitter systems that can relieve the symptoms of LPE in male patients. We aim to provide an overview of studies on neurotransmitter systems as the pathophysiological cause of LPE by investigating direct genetic research or pharmacotherapeutic interference that relieves the main symptom of LPE in male patients. This scoping review will use the PRISMA-ScR tool (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). In addition, this study will use a peer-reviewed search strategy. Systematic searches will be conducted using 5 scientific databases (Cochrane Database of Systematic Reviews, PubMed or MEDLINE, Cumulative Index to Nursing and Allied Health Literature [CINAHL], EMBASE, and Epistemonikos). Additionally, pragmatic searches for relevant information in gray literature databases will be performed. Two reviewers will independently include relevant studies in a 2-stage selection strategy. Finally, data will be extracted from the studies and charted to summarize relevant study characteristics and key findings. As of July 2022, we completed the preliminary searches according to the PRESS 2015 guidelines and started to determine the final search terms that we will use in all selected 5 scientific databases. This scoping review protocol is the first to focus on neurotransmitter pathways in LPE by combining the results from the genetic and pharmacotherapy studies. The results could help identify potential research gaps or target candidate proteins and neurotransmitter pathways in LPE for further genetic research. Open Science Framework 10.17605/OSF.IO/JUQSD; https://osf.io/juqsd. PRR1-10.2196/41301.

Influence of TPH2 and HTR1A polymorphisms on lifelong premature ejaculation risk among the Chinese Han population

Influence of TPH2 and HTR1A polymorphisms on lifelong premature ejaculation risk among the Chinese Han population