This review article is aimed at providing a summary of the presently available non-pharmacological, non-surgical technological therapies for PE, excluding cognitive or behavioral approaches. We will discuss the findings from studies that are dedicated to creating innovative technological treatment options for PE. Pelvic floor muscles (PFMs), specifically the ischiocavernosus and bulbospongiosus muscles, assume a pivotal role in the expulsion phase of ejaculation, expressed by increase in electromyographic activity during ejaculation [40]. The objective of physio-kinesiotherapy and electrostimulation is to augment the contractile strength of the perineal muscles, complemented by biofeedback to facilitate patients in mastering the recognition and contraction of PFMs, thereby strengthening the urethral sphincter. However, a comprehensive understanding of the intricate protocol dynamics is often necessitated, requiring patients to undergo several months of PFM training to gain control over the ejaculatory reflex and adeptly apply acquired skills during sexual activity [40]. [41], 40 patients with lifelong PE and intravaginal ejaculatory latency time (IELT) values below 1 min underwent a 12-week PFM rehabilitation regimen, comprising physio-kinesiotherapy, trans anal probe electro-stimulation, and thrice-weekly biofeedback sessions. Post-intervention, the mean IELT demonstrated a significant increase compared to baseline values (31.7 s vs. 146.2 s, respectively, P < 0.0001). [42] retrospectively reviewed 154 participants with baseline IELT values of 60 s or less and Premature Ejaculation Diagnostic Tool (PEDT) scores exceeding 11. The 12-week PFM rehabilitation program included physio-kinesiotherapy, trans anal probe electrostimulation, and three weekly biofeedback sessions, each lasting 20 min.
This study introduces an innovative approach to addressing lifelong PE by extending on-demand coital duration through electric stimulation of the ejaculation muscles using the In2 patch. This method shows promise as a potential on-demand, non-invasive, and drug-free treatment for PE. However, it is essential to acknowledge the study’s limitations, including a restricted participant pool, exclusion of individuals with acquired PE, short-term follow-up, a focus solely on vaginal penetration, omission of men engaged in anal penetration, exclusion of couples with shorter-term relations, and utilization of a device based on a theoretical mechanism of action. Future comparative studies are imperative to ascertain whether on-demand TENS treatment methods can match or surpass the efficacy of pharmacological agents in delaying ejaculation for patients with PE. The concept of utilizing electrical stimulation to prolong ejaculation latency time gained support from Cizmezi et al.
In this controlled study, high-frequency burst and continuous low-frequency (LF) neuromuscular electrical stimulation was applied to the rats for 30 min (n = 8 for each group including control). They found a significant difference between the groups in terms of ejaculation time (1344.71 ± 105.9, p = 0.002). Other measured PE parameters did not differ significantly between the groups (change in basal seminal vesicle pressure, seminal vesicle maximum pressure, number and interval time of seminal vesicle contractions and bulbospongiosus muscle EMG activities). They concluded that continues low-frequency neuromuscular electrical stimulation (2 Hz and 200 µs transition time) significantly prolonged the ejaculation time in rats. This study strengthens the theoretical mode of action by maintaining sub-tetanic continuous contraction that prevents the rhythmic contractions necessary for completing the ejaculatory process [46]. Of the 122 participants completing PFM rehabilitation, 111 gained control over their ejaculation reflex, resulting in a mean IELT of 161.6 s and a PEDT score of 2.3 at the intervention endpoint, indicating a significant increase from baseline IELT of 40.4 s and PEDT score of 17.0 (P < 0.0001). At the 36-month follow-up, 64% and 56% of the remaining 95 participants maintained satisfactory ejaculation control at 24- and 36-months post-intervention, respectively. Protocols utilizing PFM rehabilitation, incorporating physio-kinesiotherapy, trans-anal probe electrostimulation, and biofeedback, are characterized as protracted and cumbersome, lacking on-demand suitability during intercourse. Patients often necessitate substantial time to comprehend the intricacies of the protocol, essential for achieving control over their ejaculatory reflex and subsequently applying this knowledge during sexual activity.
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[43] proposed an alternative approach to PE treatment, utilizing transcutaneous electrical neuro stimulation (TENS) on the perineal region. The rationale was that TENS would suppress rhythmic contractions in the expulsion phase by generating a plateau action potential, through continuous stimulation of the bulbospongiosus and ischiocavernosus muscles. Anticipated benefits included hindering muscle relaxation, sustaining the muscles in a sub-tetanic contraction state, thus potentially leading to delayed ejaculation during sexual intercourse. [44] piloted a study to test this hypothesis, employing a commercial TENS device on the perineum of 23 patients with lifelong PE, with each patient serving bayer vardenafil as their own control. The study compared Masturbating Ejaculatory Latency Time (MELT) with and without TENS during self-sexual stimulation. Results indicated significantly higher mean MELT values during TENS treatment compared to self-stimulation without TENS (311.4 s vs. 124.6 s, P = 0.0009), signifying an ~4-fold increase in MELT. Notably, the absence of an established MELT threshold in the literature prompted the researchers to assume a correlation with IELT in PE patients, an assumption lacking scientific validation and constituting a significant study limitation. No patients reported erectile difficulties or severe adverse effects, although a minority experienced minor adverse effects such as discomfort during stimulation and dysuria.
This review article is aimed at providing a summary of the presently available non-pharmacological, non-surgical technological therapies for PE, excluding cognitive or behavioral approaches. We will discuss the findings from studies that are dedicated to creating innovative technological treatment options for PE. Pelvic floor muscles (PFMs), specifically the ischiocavernosus and bulbospongiosus muscles, assume a pivotal role in the expulsion phase of ejaculation, expressed by increase in electromyographic activity during ejaculation [40]. The objective of physio-kinesiotherapy and electrostimulation is to augment the contractile strength of the perineal muscles, complemented by biofeedback to facilitate patients in mastering the recognition and contraction of PFMs, thereby strengthening the urethral sphincter. However, a comprehensive understanding of the intricate protocol dynamics is often necessitated, requiring patients to undergo several months of PFM training to gain control over the ejaculatory reflex and adeptly apply acquired skills during sexual activity [40].
[41], 40 patients with lifelong PE and intravaginal ejaculatory latency time (IELT) values below 1 min underwent a 12-week PFM rehabilitation regimen, comprising physio-kinesiotherapy, trans anal probe electro-stimulation, and thrice-weekly biofeedback sessions. Post-intervention, the mean IELT demonstrated a significant increase compared to baseline values (31.7 s vs. 146.2 s, respectively, P < 0.0001). [42] retrospectively reviewed 154 participants with baseline IELT values of 60 s or less and Premature Ejaculation Diagnostic Tool (PEDT) scores exceeding 11. The 12-week PFM rehabilitation program included physio-kinesiotherapy, trans anal probe electrostimulation, and three weekly biofeedback sessions, each lasting 20 min.
Of the 122 participants completing PFM rehabilitation, 111 gained control over their ejaculation reflex, resulting in a mean IELT of 161.6 s and a PEDT score of 2.3 at the intervention endpoint, indicating a significant increase from baseline IELT of 40.4 s and PEDT score of 17.0 (P < 0.0001). At the 36-month follow-up, 64% and 56% of the remaining 95 participants maintained satisfactory ejaculation control at 24- and 36-months post-intervention, respectively. Protocols utilizing PFM rehabilitation, incorporating physio-kinesiotherapy, trans-anal probe electrostimulation, and biofeedback, are characterized as protracted and cumbersome, lacking on-demand suitability during intercourse. Patients often necessitate substantial time to comprehend the intricacies of the protocol, essential for achieving control over their ejaculatory reflex and subsequently applying this knowledge during sexual activity. [43] proposed an alternative approach to PE treatment, utilizing transcutaneous electrical neuro stimulation (TENS) on the perineal region. This study presents a novel approach to addressing lifelong PE through the extension of on-demand coital duration, achieved via electric stimulation of the ejaculation muscles using the In2 patch.
Patient-specific sensory and motor activation thresholds during perineal stimulation with the In2 patch were derived from these results. At the final visit, IELTs, Clinical Global Impression of Change (CGIC) scores, and Premature Ejaculation Profile (PEP) questionnaire outcomes were recorded. Each individual was compared to his own results, with and without the device, and comparison was also performed between the Sham and the Active groups. The primary end points evaluated the device’s efficacy as the mean change in geometric mean IELT. 51 of 59 patients completed the study.
Of those, 34 were in the Active Group, and 17 were in the Sham Group. The baseline geometric mean IELT significantly increased from 67 to 123 s (p < 0.01) in the Active Group, compared to an insignificant increase from 63 to 81 s (P = 0.17) in the Sham Group. The mean increase in IELT from baseline was 56 s in the active Group, which was significantly different from, and 3.1 times greater, than the geometric mean increase of 18 s in sham group (p = 0.01), while the geometric mean fold increases in IELTs were 1.7 and 1.2 for Active and Sham groups, respectively. The mean ratio of fold change (Active/Sham) was 1.4, significantly different from 1.0 (P = 0.02). In a subgroup analysis of subjects exhibiting improvement in IELT, 91% (31/34) of individuals in the Active Group demonstrated enhanced IELT during the treatment period compared to baseline.
Responders exhibited a mean time-fold increase in IELT vardenafil 10 mg tablet of 2.04, with a 95% confidence interval ranging from 1.68 to 2.40. No instances of serious or severe treatment-emergent adverse events (AEs) were reported. Two minor AEs occurred in the Active Group (2/186 sessions), both attributed to the study device. One participant reported “Discomfort due to device vibration in the inguinal scar site,” while another reported “Pain and discomfort during sexual intercourse in the pelvic area”; nonetheless, both individuals continued their participation in the study. Consequently, the AE rate was 1.1% in the Active Group, contrasting with 0.0% (0/70) in the Sham Group (P = 1.00). This method holds promise as a potential on-demand, non-invasive, and drug-free treatment for PE. However, it is important to note that the study’s scope was constrained by a limited number of participants, the exclusion of those with acquired PE, short-term follow-up, exclusive focus on vaginal penetration, omission of men engaged in anal penetration, exclusion of couples with shorter-term relations, and the use of a device based on a theoretical mechanism of action. As cenforce 200 uk a result of this study, the In2 patch, a miniaturized on-demand perineal TENS device, was developed for PE treatment (Virility Medical Ltd., Hod Hasharon, Israel). [45] conducted an international, bi-center, prospective, double-blind, randomized, bi-arm, sham-controlled, first-in-human clinical study to evaluate the safety, feasibility, and effectiveness of the perineal TENS device during coitus. The study enrolled 59 male patients with lifelong PE, averaging 39.8 years old.
IELT was measured by their female partner over a 2-week run-in period, and eligibility was determined based on IELT values and medical/sexual history.
Patient-specific sensory and motor activation thresholds during perineal stimulation with the In2 patch were derived from these results. At the final visit, IELTs, Clinical Global Impression of Change (CGIC) scores, and Premature Ejaculation Profile (PEP) questionnaire outcomes were recorded. Each individual was compared to his own results, with and without the device, and comparison was also performed between the Sham and the Active groups. The primary end points evaluated the device’s efficacy as the mean change in geometric mean IELT.
51 of 59 patients completed the study. Of those, 34 were in the Active Group, and 17 were in the Sham Group. The baseline geometric mean IELT significantly increased from 67 to 123 s (p < 0.01) in the Active Group, compared to an insignificant increase from 63 to 81 s (P = 0.17) in the Sham Group. The mean increase in IELT from baseline was 56 s in the active Group, which was significantly different from, and 3.1 times greater, than the geometric mean increase of 18 s in sham group (p = 0.01), while the geometric mean fold increases in IELTs were 1.7 and 1.2 for Active and Sham groups, respectively.
| Exercise Type | Frequency | Benefits | Time to See Results |
|---|---|---|---|
| Standard Kegels | 3 sets of 10 repetitions daily | Improves pelvic muscle strength | 4-6 weeks |
| Quick Contractions | 10 contractions in quick succession | Enhances ejaculatory control | 2-4 weeks |
| Resistance Kegels | Using pelvic floor devices | Greater muscle engagement | 6-8 weeks |
The mean ratio of fold change (Active/Sham) was 1.4, significantly different from 1.0 (P = 0.02). In a subgroup analysis of subjects exhibiting improvement in IELT, 91% (31/34) of individuals in the Active Group demonstrated enhanced IELT during the treatment period compared to baseline. Responders exhibited a mean time-fold increase in IELT vardenafil 10 mg tablet of 2.04, with a 95% confidence interval ranging from 1.68 to 2.40.
TPTNS therapy has found extensive application in pelvic floor physiotherapy [47]. The underlying principle of electrostimulation therapy is rooted in the intricate sensorimotor function of the posterior tibial nerve, originating from T4–S3 roots. While the emission phase of ejaculation is primarily governed by stimuli from the T12–L1 area [48], the expulsion phase is predominantly regulated at the S2–S4 level [49, 50]. Consequently, TPTNS has the potential to inhibit both the emission (through the sympathetic system) and expulsion (through the parasympathetic–somatic ejaculation system) phases of ejaculation. No instances of serious or severe treatment-emergent adverse events (AEs) were reported. Two minor AEs occurred in the Active Group (2/186 sessions), both attributed to the study device. One participant reported “Discomfort due to device vibration in the inguinal scar site,” while another reported “Pain and discomfort during sexual intercourse in the pelvic area”; nonetheless, both individuals continued their participation in the study. Consequently, the AE rate was 1.1% in the Active Group, contrasting with 0.0% (0/70) in the Sham Group (P = 1.00). This study introduces an innovative approach to addressing lifelong PE by extending on-demand coital duration through electric stimulation of the ejaculation muscles using the In2 patch. This method shows promise as a potential on-demand, non-invasive, and drug-free treatment for PE. However, it is essential to acknowledge the study’s limitations, including a restricted participant pool, exclusion of individuals with acquired PE, short-term follow-up, a focus solely on vaginal penetration, omission of men engaged in anal penetration, exclusion of couples with shorter-term relations, and utilization of a device based on a theoretical mechanism of action. Future comparative studies are imperative to ascertain whether on-demand TENS treatment methods can match or surpass the efficacy of pharmacological agents in delaying ejaculation for patients with PE. The concept of utilizing electrical stimulation to prolong ejaculation latency time gained support from Cizmezi et al. In this controlled study, high-frequency burst and continuous low-frequency (LF) neuromuscular electrical stimulation was applied to the rats for 30 min (n = 8 for each group including control). They found a significant difference between the groups in terms of ejaculation time (1344.71 ± 105.9, p = 0.002). Other measured PE parameters did not differ significantly between the groups (change in basal seminal vesicle pressure, seminal vesicle maximum pressure, number and interval time of seminal vesicle contractions and bulbospongiosus muscle EMG activities). They concluded that continues low-frequency neuromuscular electrical stimulation (2 Hz and 200 µs transition time) significantly prolonged the ejaculation time in rats. This study strengthens the theoretical mode of action by maintaining sub-tetanic continuous contraction that prevents the rhythmic contractions necessary for completing the ejaculatory process [46]. TPTNS therapy has found extensive application in pelvic floor physiotherapy [47]. The underlying principle of electrostimulation therapy is rooted in the intricate sensorimotor function of the posterior tibial nerve, originating from T4–S3 roots. While the emission phase of ejaculation is primarily governed by stimuli from the T12–L1 area [48], the expulsion phase is predominantly regulated at the S2–S4 level [49, 50]. Consequently, TPTNS has the potential to inhibit both the emission (through the sympathetic system) and expulsion (through the parasympathetic–somatic ejaculation system) phases of ejaculation.
The rationale was that TENS would suppress rhythmic contractions in the expulsion phase by generating a plateau action potential, through continuous stimulation of the bulbospongiosus and ischiocavernosus muscles. Anticipated benefits included hindering muscle relaxation, sustaining the muscles in a sub-tetanic contraction state, thus potentially leading to delayed ejaculation during sexual intercourse. [44] piloted a study to test this hypothesis, employing a commercial TENS device on the perineum of 23 patients with lifelong PE, with each patient serving bayer vardenafil as their own control. The study compared Masturbating Ejaculatory Latency Time (MELT) with and without TENS during self-sexual stimulation. Results indicated significantly higher mean MELT values during TENS treatment compared to self-stimulation without TENS (311.4 s vs.
124.6 s, P = 0.0009), signifying an ~4-fold increase in MELT. Notably, the absence of an established MELT threshold in the literature prompted the researchers to assume a correlation with IELT in PE patients, an assumption lacking scientific validation and constituting a significant study limitation. No patients reported erectile difficulties or severe adverse effects, although a minority experienced minor adverse effects such as discomfort during stimulation and dysuria. This study presents a novel approach to addressing lifelong PE through the extension of on-demand coital duration, achieved via electric stimulation of the ejaculation muscles using the In2 patch. This method holds promise as a potential on-demand, non-invasive, and drug-free treatment for PE.
However, it is important to note that the study’s scope was constrained by a limited number of participants, the exclusion of those with acquired PE, short-term follow-up, exclusive focus on vaginal penetration, omission of men engaged in anal penetration, exclusion of couples with shorter-term relations, and the use of a device based on a theoretical mechanism of action. As cenforce 200 uk a result of this study, the In2 patch, a miniaturized on-demand perineal TENS device, was developed for PE treatment (Virility Medical Ltd., Hod Hasharon, Israel). [45] conducted an international, bi-center, prospective, double-blind, randomized, bi-arm, sham-controlled, first-in-human clinical study to evaluate the safety, feasibility, and effectiveness of the perineal TENS device during coitus. The study enrolled 59 male patients with lifelong PE, averaging 39.8 years old. IELT was measured by their female partner over a 2-week run-in period, and eligibility was determined based on IELT values and medical/sexual history.