Mean Intravaginal Ejaculatory Latency Time Research Articles

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.

Prospective comparison of tadalafil 5 mg, dapoxetine 30 mg, and the combination of both in the treatment of premature ejaculation

ABSTRACT Objective To compare the efficacy of tadalafil alone, dapoxetine alone, and tadalafil with dapoxetine as a combination therapy for the treatment of premature ejaculation. Patients and Methods Eligible patients attended our andrology clinic with premature ejaculation were randomly allocated into three groups: group A (92 participants) received on-demand tadalafil, 5 mg; group B (91 participants) were given on-demand dapoxetine, 30 mg; and group C (89 participants) received on-demand combination of tadalafil, 5 mg, and dapoxetine, 30 mg. We assessed the changes in the intravaginal ejaculatory latency time (IELT) and the satisfaction scores 1, 2, and 3 months after treatment. Results Highly statistically significant improvements were found in the mean IELT and satisfaction scores 1, 2, and 3 months post-treatment in all groups (P = <0.001). Post hoc analysis suggested this improvement was more pronounced in group C (P < 0.001). Conclusion Both tadalafil and dapoxetine are effective in the treatment of patients with premature ejaculation, but the combination of both drugs gives better results.

The impact of hyperthyroidism on sexual functions in men and women: a systematic review and meta-analysis.

This study aimed to review the current knowledge on sexual dysfunction in men and women with hyperthyroidism through a systematic review and meta-analysis. Available clinical trials from the MEDLINE database were searched using a prerecorded protocol (Protocol Prospero ID: CRD42022340587), and obtained data were analyzed and reported according to the PRISMA guidelines. Pooled effect estimates were computed using a random-effects model. Twenty eligible studies were identified, of which 15 were included in this meta-analysis. The prevalence of erectile dysfunction was significantly higher in participants with hyperthyroidism than that in controls [odds ratio = 9.16 (95% confidence interval [CI], 5.0-16.5)]. Treatment of hyperthyroidism alone improved erectile functions [effect size, ES = 0.36 (95% CI, -0.01-72)] and mean intra-vaginal ejaculation latency time [ES = 0.63 (95% CI, 0.27-98)] among men with erectile dysfunction and/or premature ejaculation. The prevalence of premature ejaculation also decreased with treatment of hyperthyroidism [odds ratio = 0.11 (95% CI, 0.04-28). Women with hyperthyroidism demonstrated higher odds in female sexual dysfunction than controls [odds ratio = 4.34 (95% CI, 2.63-7.18)]. Female sexual function index scores in women with hyperthyroidism were also significantly lower than those in the controls with moderate effect sizes. An evident and reversible disruption of sexual functions under hyperthyroidism conditions was observed in both sexes.

Efficacy and Safety of Extracorporeal Shock Wave Therapy in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome and Acquired Premature Ejaculation Patients

Introduction: The aim of this study was to evaluate the efficacy and safety of extracorporeal shock wave therapy (ESWT) in patients with acquired premature ejaculation (APE) due to chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Method: Patients with APE due to CP/CPPS between January 2020 and June 2022 were included in the study. Demographic data of the patients were recorded, and the degree of their symptoms was evaluated with the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), premature ejaculation diagnostic tool (PEDT), and Premature Ejaculation Profile (PEP). The international prostate symptom index (IPSS) was also used for lower urinary tract symptoms (LUTS), and the international erectile function index-erectile function (IIEF-EF) was used to evaluate erectile functions. All patients received treatment with the Medispec Bold Li-ESWT device without using any anesthesia method (12 sessions). The changes in the symptom scores of the patients were evaluated before the treatment and at the 3rd month after the treatment. Results: A total of 42 patients were included in the study. The mean age of the patients was 43.75 ± 12.03 (20–55), and the mean BMI was 23.58 ± 7.61 (18.03–35.98) kg/m². The patients’ estimated mean intravaginal ejaculation latency time (IELT) before ESWT was 37.98 ± 21.87 s. After a total of 12 sessions of ESWT, the IIEF-EF, IPSS, NIH-CPSI, and PEP index scores of the patients showed significant improvements (p < 0.001 for each). The IELT mean increased to 74.81 ± 46.79 s (p < 0.001). Posttreatment IELT fold increase was determined as 3.25 ± 1.72 fold. A highly significant positive correlation (p = 0.032; r = 0.839) was found between the CPSI score difference and the posttreatment PEP index score. Conclusion: Li-ESWT treatment is an effective and safe treatment with positive effects on both LUTS and premature ejaculation in patients with APE symptoms due to CP/CPPS. Patients who benefit from CP treatment also have longer IELT times.

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.

(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.

Retrospective evaluation of the efficacy of daily paroxetine/tadalafil combination in patients with premature ejaculation and erectile dysfunction.

Premature ejaculation (PE) and erectile dysfunction (ED) are sexual dysfunction diseases affecting males. The phosphodiesterase type 5 (PDE5) inhibitors such as tadalafil are used to treat ED whereas selective serotonin reuptake inhibitors (SSRIs) are preferred for PE. Most of the patients with ED also suffer from PE simultaneously. The combined drug therapies are commonly preferred as they favor elevated intra-vaginal ejaculation latency time (IELT) scores and improved sexual function. The study aimed to evaluate the efficacy and safety of daily paroxetine and tadalafil combination therapy in patients with PE and ED. A total of 81 PE patients with ED were enrolled in the study. Patients were treated with daily paroxetine 20 mg and tadalafil 5 mg for 4 weeks. Pre- and post-treatment IELT, premature ejaculation profile (PEP), and International Index of Erectile Function-Erectile Function (IIEF-EF) scores of the patients were analyzed. The mean IELT and PEP index scores, and mean IIEF-EF values improved after combination therapy (p<0.001 for each). When lifelong and acquired PE+ED patients were compared, significant improvements were observed in IELT, PEP, and IIEF-EF scores in both groups (p<0.001). Even though the treatment methods are different, combined therapies to treat simultaneous PE and ED presence are effective compared to monotherapies. However, there is still no definitive treatment that can cure all subtypes of PE or ED.

Hyaluronic acid injection to coronal sulcus of the penis for the treatment of premature ejaculation: a retrospective observational study

BackgroundHyaluronic acid (HA) injection has become a burgeoning method to treat premature ejaculation (PE) due to its high biocompatibility and structural properties.PurposeIn this study, we proposed a modified technique: injecting hyaluronic acid around coronal sulcus to treat PE, aiming to decrease the complications of hyaluronic acid injection in penis while achieving similar effects.MethodA total of 85 patients who had HA injection from January 2018 to December 2019 were analyzed retrospectively in our study. 31 patients received injection at glans penis and 54 patients received injection around coronal sulcus. Intravaginal ejaculation latency time (IELT) was mainly measured to estimate the efficacy and the severity of complications was assessed between two groups.ResultsThe mean IELT was 123.0 ± 37.28 s of all patients, 124.7 ± 39.01 s of patients injecting at glans penis and 121.9 ± 36.58 s of patients injecting around coronal sulcus. IELT of all patients increased to 482.1 ± 121.7 s at 1 month, 331.2 ± 81.2 s at 3 month and 280 ± 80.4 s at 6 month. In the group of injecting at glans penis, the incidence of complications is 25.8% and it is 1.9% in the group of injecting around coronal sulcus. No severe complication was reported in both groups.ConclusionThe modified technique of injecting around coronal sulcus decreases complications and it has the potential to become a new injectable technique for treating premature ejaculation.

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 ...

A novel, on-demand therapy for premature ejaculation using a miniature trans-perineal electrical stimulator: a randomized-controlled trial

<h3>Objectives</h3> To assess the feasibility, safety, and efficacy of a miniaturized on-demand perineal Transcutaneous Electrical Stimulation (TES) Using the vPatch device, for the treatment of premature ejaculation (PE). <h3>Methods</h3> We designed a bi-center, international, prospective, randomized, double-blind, sham-controlled, clinical study. A total of 59 lifelong PE patients were included. After the screening visit (Visit 1), patients measured their intravaginal ejaculatory latency time (IELT) for a 2-week run-in period and complete the Premature Ejaculation Profile (PEP) questionnaire. At Visit 2, eligible patients tried vPatch to determine the individualized sensory and motor activation thresholds. Patients were randomized into active and sham arms in a 2:1 ratio. At Visit 3, the IELT values and PEP outcomes were recorded again. Clinical Global Impression of Change (CGIC) scores were noted. <h3>Results</h3> Of the patients, 51 completed the study, 34 in the active and 17 in the sham arm. In the active arm the Baseline Geometric Mean IELT (BGMI) was 67 seconds (s) and significantly increased by 56s (standard error (SE) 9s) to 123s (p<.0001). However, in the sham arm the BGMI was 63s and increased insignificantly by 17s (SE 12s) to 80s (p=0.1653). The increase in IELT from base line was 3.22-fold greater in favor of the active arm (p=0.0047). In the active arm 91% (31/34) of the subjects significantly improved their IELT due to treatment compared to baseline. The mean geometric time-fold in IELT, in those positive responders was 2.04 (CI 95% 1.68-2.4). 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<0.05). <h3>Conclusions</h3> IELT values and patient-reported outcome measures can be improved with TES using vPatch. This treatment may become an on-demand, noninvasive, and drug-free therapeutic option for lifelong PE. <h3>Conflicts of Interest</h3> This study was sponsored by Virility Medical Ltd

Efficacy of combination therapy with biofeedback and dapoxetine in lifelong premature ejaculation treatment: a prospective randomized study.

Premature ejaculation (PE) is a common sexual dysfunction that significantly affects the quality of life of the patient and their partner. We aimed to compare the efficacy and safety of the combination therapy with biofeedback-guided pelvic floor exercise therapy (BFT) and dapoxetine 30mg. Sixty-five patients diagnosed with lifelong PE were included in the study. Patients were divided into three groups as BFT, dapoxetine 30mg and a combination of BFT and dapoxetine 30mg. The patients were compared with the intravaginal ejaculatory latency time (IELT) pre-treatment and post-treatment 1st and 3rd months. The mean IELTs of the patients in Group 1 were 40s in pre-treatment, 115s at the end of the 4th week and 140s at the end of the 12th week. The IELT values of the patients in Group 2 were 40s in pre-treatment, 145s in the 4th week and 170s in the 12th week. The IELT values were calculated in Group 3 as 42.5s in pre-treatment, 185s in the 4th week and 205s in the 12th week When the IELT was statistically compared between the groups at 1st and 3rd months, the duration in the combination group was found to increase significantly (p < 0.001). Combination therapy with BFT and dapoxetine 30mg in lifelong PE treatment is a good alternative with a low side effect profile and acceptable continuous efficiency.

Efficacy and safety assessment of glandular augmentation with hyaluronic acid for premature ejaculation.

Glandular augmentation (GA) with hyaluronic acid (HA) is a newly developed, minimally invasive therapy for patients with premature ejaculation (PE); however, evidence supporting its efficacy is scarce. To provide a comprehensive profile of GA with HA gel in managing PE, 184 patients with PE who received GA with HA gel therapy from October 2017 to November 2019 were included and followed up for 1 year. The Fan technique was applied. Intravaginal Ejaculation Latency Time (IELT), Chinese Index of Premature Ejaculation-5(CIPE-5) and Visualised Satisfaction Index (VSI) of sexual experience were assessed at initial and 1-, 3-, 6- and 12-month post injection. A total of 71 patients with primary PE (pPE, 38.6%) and 113 patients with acquired PE (aPE, 61.4%) were enrolled. The mean IELT increased to 100.7 ± 43.2s(p < .05) for pPE patients and 359.2 ± 87.1s (p < .05) for aPE patients 1-month post injection and remained significantly higher at the end point with acceptable attenuation. The mean CIPE-5 score increased to 17.6 ± 6.4 (p < .05) in the 1st month and remained steady. The VSI scores increased to 6.6 ± 1.0 (p < .05) for patients with pPE and 7.7 ± 1.2 (p < .01) for patients with aPE. Increments in VSI in patients with aPE were significantly higher than those in patients with pPE (p < .01). No severe complications were noted. GA with HA may be an effective and safe method to treat PE. Patients with acquired PE were also more satisfied post treatment.

Effects and safety of combined hypericum perforatum and quercetine in premature ejaculation: A pilot study

ABSTRACT Introduction Premature ejaculation (PE) is a common, and under treated medical condition that affects men and their partners. Advances in clinical research in premature ejaculation (PE) over the last years have led to the development of a variety of new treatment options, including dietary supplements. Hypericum perforatum (HP), a natural supplement has demonstrated pharmacologic action to inhibit serotonin reuptake and that inhibits rat and human vas deferens contractility. These results might explain delayed ejaculation described in patients receiving HP. Quercetin is a naturally occurring bioflavonoid found in high concentrations in red wine, onions, and green tea. Therapy with the bioflavonoid quercetin provides significant symptomatic improvement in most men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Subjects with PE often show symptoms and signs compatible with CP/CPPS, as confirmed by many different studies, CP/CP are an organic risk factor for PE. Objective The purpose of the present investigation was to assess the safety and preliminary evidence of the effectiveness of a supplement that combined HP and quercetin for the treatment of PE. Methods A one-group pretest-posttest design was used in the current research. Main outcome measures were assessed using the mean stopwatch-measured Intravaginal Ejaculatory Latency Time (IELT) at baseline and after 12 weeks. The collected data were tabulated and analyzed using the Statistical Package for the Social Sciences version 22 (SPSS). Quantitative data are expressed as means ± standard deviations (SDs). For the comparison of paired variables the Wilcoxon test was used. Premature Ejaculation Diagnostic Tool (PEDT) was used for the diagnosis and as a secondary measure. The study inclusion criteria to be selected were as follows: Being over 18 years old, being in a heterosexual relationship for at least the last 6 months, having a score ≥ 11 in the PEDT and a mean self-reported IELT ≤ 2 minutes. Exclusion criteria included a history of alcohol abuse or dependence, having received medication or psychological treatment for PE in the last 6 months, suffering from diabetes or habitual use of recreational drugs. A total of 12 subjects, aged between 27 and 58 years of age (mean = 40.50 years, standard deviation (SD) = 8.31) were treated with 1 daily tablet of 650 mg of Myhixel Max®. Each tablet contained Hypereric dry extract 433.64mg, Sophora japonica L. (95% quercetin 72.27mg), 68.65mg quercetin and anti-caking agents (magnesium stearate and silico dioxide). Results In the present study, there was a significant improvement in mean IELT (mean pre = 69.6 seg (SD) = 37.8 mean post = 146.4 seg (SD) = 67.2, Wilcoxon test pre vs post p-value = 0.008). Conclusions Oral therapy with HP and quercetin was associated with a significant increase in mean IELT from baseline, with no adverse effects related to the treatment. We can conclude that this supplement in daily use has the potential to become an effective and safe treatment for patients suffering from PE, long-term durability of the response is yet to be determined. Future studies with, larger group of patients; larger follow-up and group control are needed. Disclosure Work supported by industry: yes, by New Wellness Concept S.L. A consultant, employee (part time or full time) or shareholder is among the authors (New Wellness Concept. S.L).

LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR

You have accessJournal of UrologyCME1 May 2022LBA02-11 NOVEL ON-DEMAND TREATMENT FOR LIFELONG PREMATURE EJACULATION USING TRANSCUTANEOUS PERINEAL MINI-PATCH STIMULATOR Ariki Shechter, Nicola Mondaini, Ege Can Serefoglu, Tal Gollan, Boaz Appel, and Ilan Gruenwald Ariki ShechterAriki Shechter More articles by this author , Nicola MondainiNicola Mondaini More articles by this author , Ege Can SerefogluEge Can Serefoglu More articles by this author , Tal GollanTal Gollan More articles by this author , Boaz AppelBoaz Appel More articles by this author , and Ilan GruenwaldIlan Gruenwald More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002670.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Background: Premature Ejaculation (PE) is a prevalent sexual dysfunction in men. Available treatments demonstrate limited efficacy and low treatment adherence. Objectives: To assess feasibility, safety, and efficacy of the Mini-patch, an on-demand transcutaneous perineal electrical stimulator, for the treating of PE. METHODS: Design, Setting, and Participants: Bi-center, international, prospective, randomized, double-blind, two-arm, sham-controlled, clinical study. After screening, intravaginal ejaculatory latency time (IELT) of candidates was measured. Eligibility was based on IELT values and medical/sexual history. Patients were randomized to Active and Sham device groups in a 2:1 ratio. Device safety profile was determined by incidence of treatment-emergent adverse events comparison. Outcome Measurements and Statistical Analysis: Clinical Global Impression of Change (CGIC) scores, Premature Ejaculation Profile (PEP) questionnaire outcomes, and Mini-patch safety profile. Statistical power was calculated. Primary endpoints assessed device efficacy by mean fold change in geometric mean IELT (Mini-patch vs. sham treatment compared to baseline values). Adjusted mean difference for treatments, adjusted treatment effects (Mini-patch – sham), 95% confidence intervals (CI), and 2-sided P values were obtained. RESULTS: Of 59 patients randomized, 51 completed the study: 34 in the Active and 17 in the Sham arm. Baseline geometric mean IELT was 67 seconds and significantly increased to 123 seconds (p<0.0001) in the Active group, compared to 63 seconds increasing insignificantly to 81 seconds (p=0.1653) in the Sham group. The IELT significantly increased by 3.22-fold in the Active as compared to the Sham group (p=0.0047). Overall Geometric Mean Time Fold increases of IELT in the 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. CONCLUSIONS: Mini-patch has the potential to become a leading on-demand, noninvasive, and drug-free treatments for PE. Source of Funding: Virility Medical Ltd; Hod-hasharon, Israel © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1045 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ariki Shechter More articles by this author Nicola Mondaini More articles by this author Ege Can Serefoglu More articles by this author Tal Gollan More articles by this author Boaz Appel More articles by this author Ilan Gruenwald More articles by this author Expand All Advertisement PDF DownloadLoading ...

Short- and long-term follow-up results of daily 5-mg tadalafil as a treatment for erectile dysfunction and premature ejaculation

ABSTRACT Objective To evaluate the safety and effectiveness of daily 5-mg tadalafil treatment for men who have erectile dysfunction (ED) and premature ejaculation (PE), and to assess the long-term follow-up for ED and PE improvement persistence years after the cessation of medication. Patients and Methods A prospective, single-blind, randomised study included 160 patients with ED and PE. All were evaluated using the International Index of Erectile Function (IIEF-5) questionnaire to evaluate ED and intravaginal ejaculatory latency time (IELT) for PE. Patients were subdivided into two equal groups. Group I (80 patients) treated with daily 5-mg tadalafil for 3 months, and Group II (80 patients) treated with a placebo for the same period. After 3 months of treatment and 2 years later after cessation of tadalafil, all patients were assessed for ED and PE. Results The mean (SD) IELT and IIEF-5 score pre-treatment were 37 (11.24) s and 13.2 (4.2) for Group I, while in Group II they were 35.98 (10.8) s and 13.12 (4.11), respectively. After 3 months of treatment, the mean (SD) IELT in Group I showed a highly significant improvement from 37 (11.24) s to 120.5 (47.37) s (P < 0.001) but Group II showed no significant improvement from baseline to [39.43 (13.6) s; P > 0.05]. For the IIEF-5 score, there was a highly significant improvement from baseline to 20.45 (4.5) in Group I (P < 0.001), while there was no significant difference in Group II from baseline to [15 (4.84); P > 0.05]. At 2 years after cessation of tadalafil, there was statistically significant improvement in the IELT and IIEF-5 from baseline to endpoint . Conclusion Oral daily 5-mg tadalafil was effective, tolerable, and safe treatment for patients with ED and PE. Long-term follow-up at 2 years confirmed the persistence of a significant improvement for both ED and PE. Abbreviations: ED: erectile dysfunction; IIEF-5: five-item version of the International Index of Erectile Function questionnaire; IELT: intravaginal ejaculatory latency time; OAD: once-daily; PDE5i: phosphodiesterase-5 inhibitors; PE: premature ejaculation; PRN: pro re nata

Association between 5-HTTLPR and STin2 VNTR polymorphisms in the serotonin transporter gene and clinical response of a selective serotonin reuptake inhibitor (dapoxetine) in lifelong premature ejaculation

Association between 5-HTTLPR and STin2 VNTR polymorphisms in the serotonin transporter gene and clinical response of a selective serotonin reuptake inhibitor (dapoxetine) in lifelong premature ejaculation

His452Tyr 5-HT2A polymorphism and intravaginal ejaculation latency time in Dutch men with lifelong premature ejaculation.

Lifelong premature ejaculation (LPE) may have heritable components. Selective serotonin reuptake inhibitors have been proven effective in prolonging intravaginal ejaculation latency time (IELT). Given that serotonergic pathways are involved in the ejaculation mechanism, we aimed to investigate whether His452Tyr, also known as the C1354T (RS6314) polymorphism of the 5-HT2A receptor, contributes to LPE pathogenesis and IELT differences among patients with LPE. Dutch Caucasian men with LPE (n = 65) attending the Outpatient Department of Neurosexology, HagaZiekenhuis for drug treatment for LPE in 2009 were selected and included in this case-control study. IELT during coitus was measured using a stopwatch, and all men were genotyped for the His452Tyr polymorphism. Analysis of variance (ANOVA) was performed to determine the association between the genotypes and IELTs. Mean IELTs with standard deviations were 29.7 (±20.9), 31.5 (±14.7), and 26.0 s, and the frequencies were 83.1%, 15.4%, and 1.5% for the CC, CT, and TT groups, respectively, with an average IELT of 29.9 s. No difference in mean IELT was observed between these groups. In the affected group, the frequencies of alleles C and T were 90.8% and 9.2%, respectively; whereas those among randomly selected European Caucasian male controls (n = 503) from the CEPH database were of 92.0% and 8.0%, respectively. No significant difference was observed between the groups. Therefore, no correlation was found between the His452Tyr polymorphism and IELT distribution in patients with LPE.

The effect of a penile fracture on ejaculatory and erectile functions: A cross-sectional study

Background/Aim: There is not enough data in the literature about ejaculatory and erectile functions after a penile fracture. We aimed to report the post-fracture ejaculatory and erectile function change and their relationship with the psychological condition of the patient. Methods: We retrospectively evaluated 27 patients with a penile fracture who were treated surgically. Pre-fracture and post-fracture ejaculatory and erectile functions were evaluated with Intravaginal Ejaculation Latency Time (IELT) and International Index of Erectile Function (IIEF) questionnaires. The psychological conditions of the patients after the fracture were evaluated with the Beck depression score. Results: The mean IELT was increased after penile fracture (P=0.007). The post-fracture and pre-fracture IIEF scores were similar (P=0.062). There was a positive correlation between Beck depression score and post-fracture IELT (r=0.498; P=0.008). Conclusions: According to our results, ejaculation time was longer after penile fractures. It may be related to neurogenic damage due to trauma or the post-fracture psychological condition. However, larger studies with long-term outcomes may reveal the relationship more thoroughly.

Comparison of the efficacy of low-intensity shock wave therapy and its combination with platelet-rich plasma in patients with erectile dysfunction.

We aimed to compare the efficacy of low-intensity shock wave therapy (Li-SWT) alone and its combination with platelet-rich plasma (PRP) in the treatment of patients with erectile dysfunction (ED). Between January 2015 and October 2020, patients who did not benefit from the use of phosphodiesterase type 5 inhibitors (PDE5i; 5mg/day) for at least 3months and underwent Li-SWT or Li-SWT with PRP were evaluated retrospectively. There were 93 patients who were subjected to Li-SWT only (Group 1) and 91 patients subjected to Li-SWT with PRP (Group 2). Analysis of the International Index of Erectile Function-Erectile Function Area (IIEF-EF) scores showed a significant increase in both the groups post-treatment (Group 1: from 14.33±4.39 to 23.8±4.37, p=.001; Group 2: from 17.82±3.44 to 26.3±2.55, p=.001). When the increase in the IIEF-EF scores was compared pre- and post-treatment between the groups with respect to the ED grades, there was no statistically significant difference between them. Furthermore, while the intravaginal ejaculatory latency time (IELT) in successfully treated patients of Group 1 remained the same, Group 2 presented 1.5-3.5 times (mean, 2.4) prolongation. Their mean IELT score showed an increase from 2.2 (0.8-3.5)min to 5.3 (2.8-10.5)min. Our study shows that combination treatment of Li-SWT with PRP injections is not only safe for patients with ED, but also effective and safe in prolonging the IELT.

Systematic review and meta-analysis for the value of thyroid disorder screening in men with ejaculatory dysfunction.

To demonstrate evidence from available clinical studies to clarify the scientific points that have been achieved in relation to thyroid disorders and ejaculatory dysfunction (EjD). Clinical trial articles published in English on Medline. Clinical studies that investigated the association of thyroid disorders with the ejaculatory function of subjects and the trials evaluating the effect of thyroid dysfunction treatment on the ejaculatory function of the subjects were eligible. We searched Medline with "ejaculation" and different combinations of "thyroid," "serum TSH," "serum T3," "serum T4" keywords in PubMed. Standardised mean serum thyroid-stimulating hormone (TSH) levels in premature ejaculation (PE) sufferers differed from non-PE control subjects (P=.05). Hyperthyroidism was associated with increased odds among PE subjects (OR=2.0, P=.03). Delayed ejaculation was seen with increased odds in hypothyroid patients compared with hyperthyroidism patients (OR=57, P=.0001). Serum TSH and mean intra-vaginal ejaculation latency time (IELT) of the subjects showed a correlation both before and after treatment for thyroid disorder. Treatment of thyroid disorders improved the mean IELT measures of the subjects. The overall estimate of the effect of hyperthyroidism treatment on mean IELT was .64 (P=.0001) in the random-effects model. The low quality and quantity of evidence from available studies limited the interpretation of our study findings. The causal relationship between EjD and thyroid disorders remains to be clarified. Sufferers of delayed ejaculation acquired PE subjects, and PE sufferers who have accompanying erectile dysfunction and/or anxiety may benefit from thyroid disorder investigation.