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Efficacy of Sphincter Control Training (SCT) in the treatment of premature ejaculation, a new cognitive behavioral approach: A parallel-group randomized, controlled trial.

ABSTRACT: 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.

SUBMITTER: Rodriguez JE

PROVIDER: S-EPMC6391003 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy of Sphincter Control Training (SCT) in the treatment of premature ejaculation, a new cognitive behavioral approach: A parallel-group randomized, controlled trial.

Rodríguez Jesús E JE Marzo Juan C JC Piqueras José A JA

PloS one 20190226 2

<h4>Introduction</h4>Current evidence suggests that Cognitive Behavioral therapy (CBT) has a limited role in the contemporary management of premature ejaculation (PE).<h4>Aim</h4>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.<h4>Methods</h4>The present study included 35 patients' that met diagnostic criteria for PE including intravaginal ejaculatory latency time (IELT) of ≤2 minute ...[more]

PMID: 30807583

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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.

Project description:IntroductionPremature ejaculation (PE) is defined by short ejaculatory latency and inability to delay ejaculation causing distress. Management may involve behavioral and/or pharmacological approaches.AimTo systematically review the randomized controlled trial (RCT) evidence for behavioral therapies in the management of PE.MethodsNine databases including MEDLINE were searched up to August 2014. Included RCTs compared behavioral therapy against waitlist control or another therapy, or behavioral plus drug therapy against drug treatment alone. [Correction added on 10 September 2015, after first online publication: Search period has been amended from August 2013 to August 2014.].Main outcome measureIntravaginal ejaculatory latency time (IELT), sexual satisfaction, ejaculatory control, and anxiety and adverse effects.ResultsTen RCTs (521 participants) were included. Overall risk of bias was unclear. All studies assessed physical techniques, including squeeze and stop-start, sensate focus, stimulation device, and pelvic floor rehabilitation. Only one RCT included a psychotherapeutic approach (combined with stop-start and drug treatment). Four trials compared behavioral therapies against waitlist control, of which two (involving squeeze, stop-start, and sensate focus) reported IELT differences of 7-9 minutes, whereas two (web-based sensate focus, stimulation device) reported no difference in ejaculatory latency posttreatment. For other outcomes (sexual satisfaction, desire, and self-confidence), some waitlist comparisons significantly favored behavioral therapy, whereas others were not significant. Three trials favored combined behavioral and drug treatment over drug treatment alone, with small but significant differences in IELT (0.5-1 minute) and significantly better results on other outcomes (sexual satisfaction, ejaculatory control, and anxiety). Direct comparisons of behavioral therapy vs. drug treatment gave mixed results, mostly either favoring drug treatment or showing no significant difference. No adverse effects were reported, though safety data were limited.ConclusionsThere is limited evidence that physical behavioral techniques for PE improve IELT and other outcomes over waitlist and that behavioral therapies combined with drug treatments give better outcomes than drug treatments alone. Further RCTs are required to assess psychotherapeutic approaches to PE.

Project description:BACKGROUND AND OBJECTIVE: Cognitive impairments associated with schizophrenia (CIAS) predict poor functional outcomes, but there are currently no approved pharmacological treatments for patients with CIAS. Additional cognitive stimulation may be required for pro-cognitive medications to improve efficacy, and computerized cognitive training (CCT) can be used to increase cognitive activity. A trial evaluating the effects of the novel glycine transporter inhibitor BI 425809 compared with placebo, on a background of regularly self-administered CCT in clinically stable patients with schizophrenia has commenced and its methodology is described here.MethodsThis Phase II, multinational, randomized, double-blind, placebo-controlled, parallel-group trial will randomize 200 clinically stable outpatients, aged 18-50 years with established schizophrenia and no other major psychiatric disorder, 1:1 to BI 425809 or placebo once daily for 12 weeks. Following screening, which included a 2-week CCT run-in period, patients sufficiently compliant with CCT (target: ≥ 2 h of CCT per week during CCT run-in) will be randomized. During the 12-week treatment period, all patients should complete a total of approximately 30 h of CCT. The primary endpoint is change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), after 12 weeks of treatment. Secondary endpoints include change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs. Primary and secondary endpoints will be analyzed using the Restricted Maximum Likelihood-based mixed model for repeated measures. Novel endpoints include the Balloon Effort Task to evaluate patients' motivation and the Virtual Reality Functional Capacity Assessment Tool to assess skills for daily functioning.DiscussionThis is one of the largest and longest trials to date to combine pharmacological therapy with CCT in patients with schizophrenia and will determine the benefit of combining BI 425809 pharmacotherapy with cognitive stimulation through self-administered CCT. This trial will further evaluate whether improvements in neurocognition translate into improved everyday functioning, whether self-administered CCT can be effectively implemented in a large multinational trial, and the role of motivation in neurocognitive and functional improvements.Trial registrationRegistered on Clinicaltrials.gov on March 1, 2019 (NCT03859973).

Dataset Information

Efficacy of Sphincter Control Training (SCT) in the treatment of premature ejaculation, a new cognitive behavioral approach: A parallel-group randomized, controlled trial.

Publications

Efficacy of Sphincter Control Training (SCT) in the treatment of premature ejaculation, a new cognitive behavioral approach: A parallel-group randomized, controlled trial.

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