Efficacy of Sphincter Control Training and medical device in the treatment of premature ejaculation: A multicenter randomized controlled clinical trial.
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SUBMITTER: Rodriguez JE
PROVIDER: S-EPMC8454929 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:INTRODUCTION:Current evidence suggests that Cognitive Behavioral therapy (CBT) has a limited role in the contemporary management of premature ejaculation (PE). AIM:The aim of this study was to determine the efficacy of a new CBT for the PE called Sphincter Control Training (SCT) in combination with a masturbation aid device. METHODS:The present study included 35 patients' that met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ?2 minutes and had a Premature Ejaculation Diagnostic Tool (PEDT) score ?11. Participants completed all phases of a randomized controlled clinical study with a parallel group design, which was approved by the Ethical Committee of the Hospital Morales Meseguer of Murcia (Spain).The two treatment groups completed SCT over 7 weeks. The SCT consists of four different exercises and an educational session. Its objective is to provide patients with greater knowledge, awareness, and control of the external urethral sphincter. The only difference between groups was the use of a masturbation aid device called Flip Zero (TFZ-001) from the Japanese company Tenga Co., Ltd. OUTCOMES:The main measure was the "fold increase" (FI) of the IELT, which was calculated using the geometric mean pre-treatment and post-treatment. In addition, Premature Ejaculation Profile PE was used as a secondary measure. RESULTS:The geometric mean of the measurements corresponding to the 7 weeks of treatment was calculated, and both groups were compared by means of an ANCOVA test, finding a statistically significant difference (F: 10.51, 1; p = .003) in the increase experienced by subjects in the group with the device (GWD) mean = 166.63, SD = 106.54) compared with that experienced by subjects in the group without device (GWtD) (mean = 86.99, SD = 59.98).Using Student's t-test, the Fold increase (FI) corresponding to both groups were compared. The results showed statistically significant differences (p = .008) between the measurements corresponding to the GWtD (1.38 (0.50)) and those relative to the GWD (2.69 (1.81)). CLINICAL IMPLICATIONS:The FI in the GWD at the end of the trial allow us to consider this new CBT as a potential and viable PE treatment alternative. No side effects were observed in either treatment group and it required little therapeutic input and no partner involvement. STRENGTHS & LIMITATIONS:The main limitation of this study is the lack of a 3- to 6-month follow-up of the treatment and placebo control. CONCLUSIONS:This SCT exercise program combined with the use of a masturbation device shows promise because has numerous advantages in relation to current recommended treatments in patients with PE.
| S-EPMC6391003 | biostudies-literature
Project description:BackgroundThe aim of this study is to compare the results of stop-start technique with stop-start technique together with sphincter control training applied in the treatment of premature ejaculation.MethodsThis research was conducted as a pre-test post-test quasi-experimental study. The sample of the study consisted of 80 men. The study was conducted on men who applied to the urology outpatient clinic of LIV Hospital, a prıvate hospital, in Gaziantep, Turkey, between 01 October 2021 and 01 March 2022. "Personal Information Form", "Intravaginal Ejaculation Latency Time (IELT)", "Fold Increase Intravaginal Ejaculation Latency Time (F-IELT)" "Premature Ejaculation Diagnostic Tool (PEDT) Questionnaire" and "Arabic Index Premature Ejaculation (AIPE)" were used as the data collection tools. Behavioral therapy, consisting of a total of 6 sessions, was applied once every two weeks, with each session lasting for 45 minutes. After 3rd and 6th months from the beginning of the application, the data collection tools were applied again. "Stop-Start Technique (Group A)" and "Stop-Start Technique and Sphincter Control Training (Group B)" were used in the treatment.ResultsIn both groups, the IELT and AIPE values after 3rd and 6th months from the beginning of the application were statistically higher than those obtained before (p<0.05). IELT and AIPE values increased more in Group B than Group A (p<0.05). F-IELT values after 6th months from the beginning of the application were found to be statistically significant with a low level of effect size than those obtained before (p<0.05, Cohen's d = 0.027). In both groups, the PEDT values in the 3rd and 6th months after the application were statistically lower than those seen before (p<0.05). PEDT value decreased more in Group B than Group A (p<0.05). The differences between the two groups' IELT (Cohen's d = 0.011), AIPE (Cohen's d = 0.044), and PEDT (Cohen's d = 0.066) values in the 3rd month after the application and IELT (Cohen's d = 0.025), AIPE (Cohen's d = 0.048), and PEDT (Cohen's d = 0.024) values in the 6th month after the application were found to be clinically weak.ConclusionsIt was determined that the stop-start technique given to men with premature ejaculation increased the time spent in the vagina and eliminated the problem of premature ejaculation. It was determined that the stop-start technique in combination with sphincter control training were more effective than the stop-start technique alone.
| S-EPMC10414676 | biostudies-literature
Project description:Premature ejaculation (PE) is the most common sexual disorder. It affects 20%-30% of adult men; the aetiology of this condition has not yet been elucidated. The aim of this study is to evaluate the efficacy, safety, tolerability, undesirable effects and improved satisfaction with sexual intercourse with tramadol hydrochloride at different dosages for the treatment of PE. A total of 300 patients who presented with lifelong (primary) PE were included in this study. The study was performed for 28 weeks, in which placebo (starch tablet) was given for 4 weeks, and active ingredient (tramadol hydrochloride) was administered at different therapeutic dosages for 24 weeks. Patients were divided into three equal groups, each consisting of 100 patients. The first group (A) was given tramadol hydrochloride capsule 25 mg. The second group (B) was given tramadol hydrochloride capsule 50 mg. The third group (C) was given tramadol hydrochloride capsule 100 mg. All of the 300 participants included completed the study voluntarily. The age of the patients varied from 25 to 50 years. After the treatment period, the recorded data were collected for each group and analysed. The results showed a highly significant increase in the mean intravaginal ejaculatory latency time (IELT) in all groups compared to baseline data (P<0.0001). We concluded that using tramadol hydrochloride at different doses on demand for the treatment of PE is effective, safe and tolerable, with minimal undesirable effects, and approval for this indication should be sought.
| S-EPMC3739134 | biostudies-other
Project description:PurposePremature ejaculation (PE) is one of the most common male sexual dysfunctions. Local anesthetics (LAs) and dapoxetine are frequently used to treat PE; however, previous studies show variable efficacy. This study aims to determine the efficacy of LAs and dapoxetine using a novel classification based on neurophysiological tests.Materials and methodsThis multicenter cohort study enrolled adult men (568) with an intravaginal ejaculatory latency time (IELT) ≤2 minutes. Patients were divided into 4 groups according to the results of neurophysiological tests and assigned different treatments for 12 weeks: 1) penile sensory hyperexcitability type (Sens)-LAs; 2) penile sympathetic hyperexcitability type (Symp)-dapoxetine; 3) mixed type (Mixed)-both LAs and dapoxetine; 4) normal type (Norm)-both LAs and dapoxetine. Self-estimated IELT and patient-reported outcomes were recorded.ResultsThe total percentage of men achieving IELT >2 minutes and ≥5 minutes after treatment were 82.7% and 76.7%, respectively. For men with abnormal results of neurophysiological tests, 401 (86.6%) had improved IELT >2 minutes after the 12-week treatment course, in which 375 (81.0%) achieved IELT ≥5 minutes. All patient-reported outcome measures improved in each group after 12 weeks of treatment, with greater improvements among those with abnormal neurophysiological tests.ConclusionsThe efficacy of LAs and dapoxetine increased in PE patients with abnormal results of neurophysiological tests. This novel classification of PE using neurophysiological tests could help guide and improve efficacy of PE therapies.
| S-EPMC8667790 | biostudies-literature
Project description:BackgroundPhysical exercise may alleviate premature ejaculation symptoms, a prevalent male sexual dysfunction linked to a series of negative outcomes for men and their partners.ObjectiveWe investigated the effectiveness of high-intensity interval training (HIIT) and slow breathing interventions on premature ejaculation symptoms and their relation to autonomic activity and attention regulation.MethodChinese adult men (N = 76, M = 21.89, SD = 3.32) with premature ejaculation completed one of the two-week interventions in their homes or as participants in a normal breathing control group; they reported their age, height, weight, physical activity level, premature ejaculation symptoms, and attention regulation. In the HIIT group, 26 participants engaged in a 7-minute HIIT each day. In the slow breathing group, 25 participants performed 7-minute slow breathing exercises per day while the 25 participants in the normal breathing group similarly performed normal breathing exercises. All participants measured their heart rate once before and five times (with one-minute intervals) after the intervention. When participants had penile-vaginal sex with their partners, they measured their heart rate once after ejaculation.ResultsTime × Intervention interaction was significant with lower levels of premature ejaculation symptoms on Days 12, 13, and 14 in the HIIT group (M ± SD = 16.19 ± 3.45, 15.96 ± 3.43, and 15.15 ± 3.62) compared to the normal breathing group (M ± SD = 17.68 ± 3.06, 17.68 ± 3.15, and 17.44 ± 3.25). Higher levels of attention regulation were associated with fewer premature ejaculation symptoms. We also found that a larger increase in heart rate from resting to after sex was associated with fewer premature ejaculation symptoms.ConclusionCompared to the control group, the efficacy of two weeks of HIIT exercise in mitigating PE symptoms suggests its potential as a novel treatment for PE.
| S-EPMC11017278 | biostudies-literature
Project description:Premature ejaculation (PE) is a highly prevalent male sexual dysfunction that is often neglected, presenting a currently unmet therapeutic need. The classification of PE has historically been varied and at times ambiguous, contributing to inaccurate prevalence estimates. This review uses the International Society for Sexual Medicine (ISSM) definition of PE, which includes reduced ejaculatory latency, lack of control and associated negative personal consequences. Patient assessment and management options differ depending on the classification of PE and it is the role of the clinician to appropriately classify patients and be aware of the correct management strategies. This review provides an overall background of PE in terms of classification and underlying physiology, patient assessment and management strategies along with the scientific rationale for treatment. Patients with lifelong and acquired PE are most likely to benefit from combination therapy of pharmacological treatment in the form of selective serotonin re-uptake inhibitor dapoxetine, psychosexual behavioural therapy and psychological therapy.
| S-EPMC6915345 | biostudies-literature
Project description:Premature ejaculation (PE) is associated with decreased quality of life, lower confidence and self-esteem, and higher levels of depression, anxiety, and interpersonal difficulties. Here we investigated the effectiveness of vibrator-assisted start-stop exercises for treatment of PE, and whether the treatment effect could be enhanced by an additional psychobehavioral intervention. Fifty participants with a mean age of 41.7 years were included and randomized into two treatment groups and a waiting list control group. Participants were instructed to perform start-stop exercises while stimulating the penis with a purpose-made vibrator, 3 times a week for 6 weeks. Additionally, participants in one of the treatment groups received additional psychoeducation and performed mindfulness meditation-based body scan exercises three times a week. Data were gathered through online questionnaires before and after treatment, as well as 3 and 6 months after treatment. The interventions reduced PE symptoms with large effect sizes (partial η2 = .20 across the three groups, d [95% CI] = 1.05 [.27, 1.82] and 1.07 [.32, 1.82] for treatment groups compared to waiting list control group). The additional psychobehavioral intervention did not further reduce PE symptoms, but did decrease PE-associated negative symptoms such as levels of sexual distress, anxiety, and depression. No side effects were reported. Vibrator-assisted start-stop exercises can be offered as an adequate treatment option for PE.
| S-EPMC7300103 | biostudies-literature
Project description:BACKGROUND:Premature ejaculation (PE) is the most common male sexual complaint. Off-label oral selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed for the treatment of PE. Dapoxetine is a short-acting SSRI specifically designed for on-demand use. The objective of this communication is to summarize the clinical and physiological evidence regarding the role of the serotonergic pathway and specifically dapoxetine in the treatment of PE. METHODS:A PubMed search was conducted on articles reporting data on dapoxetine for the treatment of PE. Articles describing the pathophysiology and treatment options for PE were additionally included for review. RESULTS:The etiology of PE is multi-factorial in nature. There are many treatment options for PE such as psychological/behavioral therapy, topical anesthetic agents, phosphodiesterase type 5 (PDE-5) inhibitors, and tramadol hydrochloride. SSRIs play a major role in PE treatment. Animal and clinical studies in addition to its pharmacokinetic document dapoxetine's clinical efficacy and safety for on-demand treatment of PE. CONCLUSIONS:Dapoxetine demonstrates clinical efficacy and a favorable side effect profile. Dapoxetine is currently the oral drug of choice for on-demand treatment of PE.
| S-EPMC4708110 | biostudies-literature
Project description:Over the past 20-30 years, the premature ejaculation (PE) treatment paradigm, previously limited to behavioural psychotherapy, has expanded to include drug treatment. Pharmacotherapy for PE predominantly targets the multiple neurotransmitters and receptors involved in the control of ejaculation which include serotonin, dopamine, oxytocin, norepinephrine, gamma amino-butyric acid (GABA) and nitric oxide (NO). The objective of this article is to review emerging PE interventions contemporary data on the treatment of PE was reviewed and critiqued using the principles of evidence-based medicine. Multiple well-controlled evidence-based studies have demonstrated the efficacy and safety of selective serotonin reuptake inhibitors (SSRIs) in delaying ejaculation, confirming their role as first-line agents for the medical treatment of lifelong and acquired PE. Daily dosing of SSRIs is likely to be associated with superior fold increases in IELT compared to on-demand SSRIs. On-demand SSRIs are less effective but may fulfill the treatment goals of many patients. Integrated pharmacotherapy and CBT may achieve superior treatment outcomes in some patients. PDE-5 inhibitors alone or in combination with SSRIs should be limited to men with acquired PE secondary to co-morbid ED. New on-demand rapid acting SSRIs, oxytocin receptor antagonists, or single agents that target multiple receptors may form the foundation of more effective future on-demand medication. Current evidence confirms the efficacy and safety of dapoxetine, off-label SSRI drugs, tramadol and topical anaesthetics drugs. Treatment with α1-adrenoceptor antagonists cannot be recommended until the results of large well-designed RCTs are published in major international peer-reviewed medical journals. As our understanding of the neurochemical control of ejaculation improves, new therapeutic targets and candidate molecules will be identified which may increase our pharmacotherapeutic armamentarium.
| S-EPMC5001989 | biostudies-literature
Project description:The purpose of this analysis is to assess the efficacy and safety of phosphodiesterase-5 inhibitors (PDE5Is) for the treatment of premature ejaculation (PE). A comprehensive search was performed to ascertain from trials about PDE5Is for the treatment of PE and compare the results, including intravaginal ejaculatory latency time (IVELT), score of sexual satisfaction scale, and side effects, between the group treated with PDE5Is and that treated with placebo. Seven studies involving a total of 471 patients were included in this meta-analysis. This analysis showed that patients who were treated with PDE5Is had significantly increased IVELT (mean difference [MD] 2.60; 95% CI [1.85, 3.36]; p < .00001) and score of sexual satisfaction scale (MD 2.04; 95% CI [0.78, 3.30]; p = .002) compared with the group on placebo. More patients had side effects while taking PDE5Is, such as headache, dizziness, flushing, and nasal congestion. PDE5Is were significantly more effective than placebo in the treatment of PE. Side effects were more common among patients who were treated with PDE5Is.
| S-EPMC7233005 | biostudies-literature