Premature Ejaculation Profile 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.

Effect of Serum Vitamin B12 Levels on Premature Ejaculation.

To assess the impact of vitamin B12 levels in the failure of the dapoxetine used in premature ejaculation (PE) treatment. Experimental study. Place and Duration of the Study: Andrology Clinic, between May and December 2020. Patients with premature ejaculation complaints completed the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire. Patients were also asked to fill in the Premature Ejaculation Profile (PEP) surveys. Intravaginal ejaculation latency time (IELT) were recorded based on the estimates of patients. Serum vitamin B12 levels were evaluated based on blood samples. All patients were advised to use dapoxetine 30 mg, 1-3 hours prior to intercourse. After four weeks, patients were asked to complete the PEP questionnaire again. IELT times were recorded. A total of 62 patients were included in the study. A total of 39 patients (62.90%) were satisfied with the treatment of the dapoxetine. In comparison to patients who benefited from dapoxetine treatment and those who did not, vitamin B12 levels of patients who did not benefit from dapoxetine were found to be significantly lower (p=0.005). Vitamin B12 deficiency can reduce the effectiveness of dapoxetine treatment in patients with PE. It is important to evaluate serum vitamin B12 levels for the evaluation of patients with PE. Premature ejaculation, Dapoxetine, Vitamin B12, Serotonin, Treatment.

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.

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.

Radiofrequency pulse modulation of the penile dorsal nerve for the treatment of premature ejaculation: evaluation of effectiveness

Introduction. Premature ejaculation (PE) is the second most common male sexual dysfunction with a significant negative impact on quality of life. A significant number of conservative and surgical methods for the treatment of PE are proposed, but their effectiveness and, in some cases, safety, remain the subject of discussion.Objective. To study the effectiveness of pulsed radiofrequency impulse neuromodulation (RPN) with different modes on the penile dorsal nerve in treatment of patients with premature ejaculation.Materials &amp; methods. Two groups of PE-patients participated in a prospective multicenter study: Group 1 — 11 patients aged 22 – 34 years; Group 2 — 12 patients aged 23 – 34 years. Group 1 received pulsed RPN at a temperature of 42°C, a stimulation frequency of 2 Hz, 45 V, and a duration of 180 seconds; in Group 2 — pulsed RPN at a temperature of 50 °C and the same frequency and duration of stimulation as Group 1. All patients before and after treatment measured intravaginal ejaculation latency time (IELT) and completed a premature ejaculation profile (PEP). The results were evaluated after 30 days.Results. In both groups, there was a statistically significant increase in IEDT and PEP. Thus, in Group 1, IELT increased from 58 to 101.9 seconds, PEP from 3.8 to 12.6 points. In Group 2, IELT increased from 66.5 to 210.9 seconds, PEP from 3.2 to 12.6 points. At the same time, in Group 2, IELT increased by 107% more than in Group 1. No significant side effects were observed in both groups.Conclusion. RPN appears to be a very promising treatment for premature ejaculation, as it is a minimally invasive, safe, and reversible procedure. The technique of influencing the penile dorsal nerve at an electrode temperature of 50 °C compared to 42 °C seems to be more effective, however, additional studies are needed.

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.

A randomized controlled trial of combined low-intensity extracorporeal shockwave therapy and Dapoxetine use in the management of lifelong premature ejaculation

We aimed to evaluate the efficacy of combined low-intensity extracorporeal shockwave therapy (LI-ESWT) and dapoxetine administration for the treatment of lifelong premature ejaculation (LPE) in comparison to LI-ESWT and dapoxetine alone. In the randomized controlled trial, 212 men diagnosed with LPE were enrolled. The participants were randomized into four subgroups: control (n = 50), dapoxetine (n = 56), LI-ESWT (n = 50) and LI-ESWT + dapoxetine (n = 56). The intravaginal ejaculation latency (IELT), premature ejaculation profile (PEP), and Global Impression of Change (GIC) were evaluated. There were substantial improvements in the fold-increase of the IELT (F-IELT), and PEP and GIC-I scores in both the dapoxetine (p &lt; 0.001) and LI-ESWT + Dapoxetine (p &lt; 0.001) groups than in the control and LI-ESWT groups. Although the LI-ESWT group demonstrated a minor improvement in the F-IELT score (p = 0.04), there were no noticeable improvements in the PEP (p = 0.12) and GIC-I (p = 0.15) scores. In conclusion, a combination of dapoxetine administration and LI-ESWT might be more effective in treating LPE than LI-ESWT or dapoxetine alone, indicating a potential synergistic effect.

Erektil disfonksiyon şikâyeti ile başvurup eşlik eden prematür ejakulasyonu olan heteroseksüel hastalarda günlük tadalafil ve sertralin kombinasyon tedavisinin etkinliği ve güvenilirliği

Efficacy and safety of daily tadalafil and sertraline combination therapy in heterosexual patients presenting with erectile dysfunction and concomitant premature ejaculation OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of daily tadalafil 5 mg and sertraline 50 mg treatment in 3-month follow-up in patients presenting with erectile dysfunction (ED) complaints and accompanying premature ejaculation (PE) symptoms. MATERIAL and METHODS: This prospective, observational single-arm study was conducted between March and September 2021 among patients suffering from ED and concomitant Lifetime/acquired PE. The Turkish validity of the International Erectile Function-Erectile Function Index (IIEF-EF) was used for the diagnosis of ED in the patients. The patients filled the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire for the diagnosis of PE. Additionally, the Premature Ejaculation Profile (PEP) score was filled. A detailed medical history was taken from all patients and a complete physical examination was performed. After a fourweek follow-up period, patients were given 5 mg tadalafil and sertraline 50 mg tablets daily. The IELT durations of the patients were recorded after 12 weeks of treatment. Premature ejaculation profile and IIEF-EF questionnaires administered to the patients at the beginning were filled again. In addition, the Global Impression of Change (GIC) questionnaire was applied in terms of treatment satisfaction. RESULTS: A total of 71 patients were included in the study. Sixty-three patients completed the study (88.73%). As a result of 3-month daily tadalafil 5 mg + sertraline 50 mg combination therapy, the geometric mean IELT, PEP index scores and subgroup scores of the patients improved and a statistically significant increase in the IIEF-EF scores (p&lt;0.001). In addition, considering the GIC questionnaire, 81.69% (58/71) of the patients stated that they were satisfied with the treatment. CONCLUSION: In conclusion, daily administration of tadalafil and sertraline provides an effective and reliable objective and subjective improvement in the management of patients with ED and accompanying PE. Keywords: premature ejaculation, erectile dysfunction, sertraline, tadalafil, IELT

Селективная криоаблация нервов полового члена в качестве метода лечения преждевременной эякуляции.

Introduction. Premature ejaculation (PE) is the second most common male sexual dysfunction with a significant negative impact on quality of life. To date, there is no satisfactory treatment for PE. Surgical methods of treatment are based on reducing the sensitivity of the glans penis by various methods, the main of which is selective dorsal neurotomy (SDN). Recently, methods have been developed for temporary demyelination of the dorsal nerve of the penis using cryoablation. This article discusses the results of selective minimally invasive cryoablation for the treatment of PE. as a treatment for premature ejaculation. Materials and methods. Materials and methods. The methods of SDN by the criablation method are described. The study involved 29 patients aged 22 to 35 years (mean age 28.7 years). All patients met the Criteria for Premature Ejaculation. Patients filled out the Premature Ejaculation Profile and recorded the time of Intravaginal Ejaculation Latency Time (IELT) before and after 3 months after SDN by cryoablation. Results. After the operation average IELT increased from of 75.8 seconds to 227.6 seconds (+298%), the average Premature Ejaculation Profile score increased from 3.6 to 11.35 points (+315%). Conclusions. Selective minimally invasive cryoablation of penile nerves is a promising treatment for premature ejaculation. However, additional studies with a larger number of participants are needed.

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

Evolving Role of Silodosin for the Treatment of Urological Disorders - A Narrative Review.

Use of α-androgenic receptor blockers remains a mainstay therapeutic approach for the treatment of urological diseases. Silodosin is recommended over other α-blockers for the treatment of lower urinary tract symptoms (LUTS) and benign prostate hyperplasia (BPH), due to its high α1A uroselectivity. Current research data suggest that silodosin is efficacious in the management of various urological diseases. Thus, we herein review the current evidence of silodosin related to its efficacy and tolerability and appraise the available literature that might ultimately aid in management of various urological conditions at routine clinical practice. Literature reveals that silodosin is beneficial in improving nocturia events related to LUTS/BPH. Silodosin exerts effect on relaxing muscles involved in detrusor obstruction, therefore prolonging the need for patients undergoing invasive surgery. Silodosin treatment, either as a monotherapy or combination, significantly improves International Prostate Symptom Score (IPSS) including both storage and voiding symptoms in patients with BPH/LUTS. Patients on other treatment therapies such as phosphodiesterase 5 inhibitors or other α-blockers are well managed with this drug. Steadily, silodosin has proved beneficial in the treatment of other urological disorders such as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), overactive bladder/acute urinary retention (AUR), premature ejaculation (PE), and prostate cancer post brachytherapy-induced progression. In patients with distal ureteral stones, silodosin treatment is beneficial in decreasing stone expulsion time without affecting stone expulsion rate or analgesic need. Moreover, there were significant improvements in intravaginal ejaculation latency time, quality of life scores, and decrease in PE profile among patients with PE. Silodosin has also demonstrated promising results in increasing the likelihood of successful trial without catheter in patients with AUR and those taking antihypertensive drugs. Reports from Phase II studies have shown promising role of silodosin in the treatment of CP/CPPS as well as facilitating ureteral stone passage. From the robust data in this review, further silodosin treatment strategies in the management of different urological conditions need to be focused on.

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 ...

Efficacy of Dapoxetine in the Treatment of Patients With Lifelong Premature Ejaculation as an Alternative to Sertraline Therapy.

IntroductionBefore dapoxetine was approved for the treatment of lifelong premature ejaculation (LPE) in China, daily dosing with off-label sertraline was common.AimTo investigate the efficacy of dapoxetine in the treatment of patients with LPE as an alternative to sertraline therapy.MethodsThis prospective study included LPE patients who previously attempted treatment with sertraline and who agree to receive dapoxetine therapy in our hospital from January 2020 to March 2021. Patients who received any PE therapy in the two months prior to the dapoxetine therapy were excluded. All patients received dapoxetine 30 mg (taken 1–3 hours before sexual intercourse) for 12 weeks, and they were not taking sertraline during the trial.Main Outcome MeasureData on their intravaginal ejaculatory latency time and premature ejaculation profile were recorded before and after the dapoxetine treatment. Clinical Global Impression of Change scores and data on Treatment-Emergent adverse events were collected after treatment.ResultsA total of 144 patients with LPE completed this study; including 64 patients who reported that previous sertraline treatment was satisfactory (group A) and 80 patients for whom previous sertraline therapy was unsatisfactory in treating PE (group B). Both groups experienced significantly increased intravaginal ejaculatory latency time. Dapoxetine therapy was reported satisfactory by 67.5% of patients with LPE in whom sertraline therapy unsatisfactory according to their Clinical Global Impression of Change score, which was not different from those who reported this result in group A (62.5%). Similar outcomes were also reported for premature ejaculation profile and treatment-emergent adverse events.Conclusion: Although both dapoxetine and sertraline are selective serotonin re-uptake inhibitors, dapoxetine therapy is satisfactory in 67.5% of patients with LPE in whom sertraline treatment unsatisfactory, and the effect of dapoxetine was independent of the effect of sertraline.Liu G, Yin Y, Zhang L. et al., Efficacy of Dapoxetine in the Treatment of Patients With Lifelong Premature Ejaculation as an Alternative to Sertraline Therapy. Sex Med 2021;10:100473.

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

A comprehensive assessment of genetic variation in serotonin transporter gene (5-HTTLPR+rs25531) and the response to dapoxetine in Chinese patients with premature ejaculation.

This study was to explore whether serotonin transporter gene-linked polymorphic region polymorphisms (5-HTTLPR+rs25531) influence the response to dapoxetine treatment in a Chinese population with premature ejaculation (PE). 112 patients with PE re-enrolled from our previous study received dapoxetine monotherapy. At the endpoint, patients with S'S' had a significant increased risk of nonresponse compared with L' carriers (p<.001). The improvement in S'S' genotype was significantly lower in premature ejaculation profile (PEP) items of 'control over ejaculation' (p=.035) and 'distress related to ejaculation' (p=.017) than that in L' carriers. As to clinical global impression of change (CGIC), results in S'S' subjects showed significantly lower scores (p=.008) and a less satisfaction rate reporting at least 'better' (p=.020) compared with L' carriers. Moreover, our findings suggested that patients with S'S' were more likely to develop adverse effects (AEs) compared with L' carriers (p=.040). This study suggests that PE patients bearing the S'S' genotype have an inferior comprehensive efficacy and safety of dapoxetine treatment, which consist of poorer response in IELTs, less improvement in patient-reported outcome (PRO) measures and greater incidence of AEs, than L' carriers. Variants of triallelic 5-HTTLPR may play a major role as a predictor of treatment response to dapoxetine.

Reproductive and Sexual Health in Males with Physical, Hearing, and Vision Disabilities

Objective This study aimed to determine reproductive health, sexual functions, and sexual satisfaction levels of males with disabilities. Methods: The study had a cross-sectional, descriptive, and correlational design and was conducted on 136 males with disabilities. Data was collected using an introduction form, International Index of Erectile Function, the Erectile Performance Anxiety Index (EPAI), the Premature Ejaculation Profile (PEP), and the Sexual Satisfaction Scale (SSS). Results: The total EPAI score was 19.86 ± 8.98(10–50), the total PEP score was 9.91 ± 4.20(0–16) and the total SSS score was 86.79 ± 18.20(44–119). Conclusions: Education and counseling on reproductive and sexual health should be given based on their individual needs.

Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study.

IntroductionDapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.AimThe aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.MethodsPhase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.Main Outcome MeasureSelf-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.ResultsAdverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.ConclusionThe results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE.J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.

Efficacy and Safety of Penile Girth Enhancement Using Hyaluronic Acid Filler and the Clinical Impact on Ejaculation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Active-Controlled Trial.

PurposeWe aimed to evaluate the efficacy and safety of penile girth enhancement (PGE) using hyaluronic acid (HA) filler with different physical properties from previous studies. Additionally, we evaluated the clinical impact on ejaculation after PGE.Materials and MethodsThis was a prospective, patient/evaluator-blinded, randomized, active-controlled, multicenter trial. Patients recruited between December 2017 and March 2018 were randomly assigned to the HA filler or control group (polylactic acid [PLA] filler). Penile girth, satisfaction level, Premature Ejaculation Profile (PEP), and self-estimated intravaginal ejaculation latency time (IELT) were assessed at baseline and at 24 weeks post-injection.ResultsSixty-four subjects (32 in each group) completed the trial. The mean increase in girth was 22.74±12.60 mm and 20.23±8.73 mm in the HA and control groups, respectively. Satisfaction level regarding penile appearance and sexual life significantly increased in both groups. There was no statistically significant difference between the groups in terms of increase in penile girth or change in satisfaction level. Both groups showed significant improvements in PEP index scores. Self-estimated IELT also significantly increased in the HA group (from 5.36±3.51 to 7.86±4.73 minutes, p=0.0001) and control group (from 5.23±3.55 to 6.43±4.22 minutes, p=0.021). No serious adverse events (AEs) were reported.ConclusionsPGE with HA and PLA fillers resulted in significant enhancement of girth without serious AEs with no significant differences. Furthermore, PGE using filler improved clinical symptoms related to ejaculation.