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临床试验/NCT05517694
NCT05517694已完成不适用

Effect of Respiratory Exercises Applied In Addition to Pelvic Floor Exercises and Behavioral Therapy Methods on the Intravaginal Ejaculation Latency Time In Individuals With Premature Ejaculation Patients

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2022年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Intravaginal Ejaculatation Latency Time(IELT)

研究概览

简要总结

According to recent epidemiological studies, premature ejaculation (PE) is accepted as the most common sexual dysfunction in men, with a frequency of up to 20%.According to the definition made by the International Society for Sexual Medicine (ISSM) in 2014, PE: 'Ejaculation (lifelong PE) that is always or almost always around 1 minute after the first sexual experience, or, ejaculation time can be reduced to 3 minutes.

Male pelvic floor muscle function also plays a role in coordinating ejaculation. Pelvic floor therapy has been found to improve control over ejaculation and increase intravaginal ejaculatory delay times (IELT) in men with premature ejaculation and pelvic floor muscle dysfunction.

Behavioral treatments consist of physical techniques that will help men's sexual development, delaying ejaculation and increasing sexual self-confidence. Specific physical techniques include: The "stop-start" technique developed by Semans involves the person or their partner, the penis is stimulated until you feel the urge to ejaculate, then it stops until the feeling goes away and the feeling goes away; this is repeated several times before allowing ejaculation to occur.

The pelvic floor muscles have respiratory functions, and most of them have been investigated in studies on urological diseases. Focusing on lower abdominal respiration, it was observed that it was associated with a significant increase in whole blood serotonin 5-hydroxytryptamine (5-HT) levels . One hypothesis proposed for the pathophysiology of premature ejaculation is that high 5-HT is associated with ejaculatory control.

Our purpose is to investigate the effect of adding breathing exercises in addition to pelvic floor rehabilitation and behavioral treatment methods on ejaculation time in individuals with premature ejaculation.

详细描述

INTRODUCTION According to recent epidemiological studies, premature ejaculation (PE) is accepted as the most common sexual dysfunction in men, with a frequency of up to 20%. According to the definition made by the International Society for Sexual Medicine (ISSM) in 2014, PE: 'Ejaculation (lifelong PE) that is always or almost always around 1 minute after the first sexual experience, or, ejaculation time can be reduced to 3 minutes. A male sexual dysfunction characterized by clinically significant and bothersome shortening (acquired PE) up to and including an inability to always or almost always delay ejaculation at vaginal penetrations, and negative personal problems such as stress, distress, frustration, and/or sexual avoidance.

Ejaculation is a highly complex process that requires the coordination and efferent nerve interaction of the motor and sensory areas of the brain and spinal motor areas, as well as sensory receptors and afferent nerve pathways. Ejaculation is controlled by various neurotransmitters distributed throughout the supraspinal and spinal nuclei. In animal studies, serotonin [5-hydroxytryptophan (5-HT)], dopamine (DA) and oxytocin (OT), opioids, gamma aminobutyric acid (GABA), nitric oxide (NO) and norepinephrine (NE); GABA, OT, 5-HT and Substance P at the spinal cord level; Peripheral NE, acetylcholine (Ach), NO, OT, purines (P2), 5-HT and sensory receptors have been shown to be involved in ejaculation.

Despite pelvic floor physiotherapy, which represents a conservative, modifiable, non-invasive, non-pharmacological and non-surgical intervention in the treatment of male sexual dysfunction, the biological relationship between pelvic floor function and male sexual function is rarely emphasized.

Male pelvic floor dysfunction has been associated with ejaculation and orgasm dysfunction as well as erectile dysfunction. Male pelvic floor muscle function also plays a role in coordinating ejaculation. Pelvic floor therapy has been found to improve control over ejaculation and increase intravaginal ejaculatory delay times (IELT) in men with premature ejaculation and pelvic floor muscle dysfunction.

Behavioral treatments consist of physical techniques that will help men's sexual development, delaying ejaculation and increasing sexual self-confidence. Specific physical techniques include: The "stop-start" technique developed by Semans involves the person or their partner, the penis is stimulated until you feel the urge to ejaculate, then it stops until the feeling goes away and the feeling goes away; this is repeated several times before allowing ejaculation to occur. The goal is to learn and recognize feelings of arousal and to improve control over ejaculation. The "squeeze" technique proposed by Masters and Johnson, stimulates the penis until you feel the urge to ejaculate, then tightens the glans penis until the urge to ejaculate passes; this is repeated without allowing ejaculation to occur.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The study will be double blind (both participants and assessor blinded)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •IELT < 60 seconds
  • •PEDT > 11
  • •Persons included in the study have been in a stable relationship with a partner for at least 6 months and have sexual intercourse once a week or more

排除标准

  • •Individuals with erectile dysfunction
  • •Individuals with prostatitis
  • •Those who have a psychiatric disorder and take medication for this reason

研究组 & 干预措施

pelvic floor exercises, behavioral therapy and respiratory exercises group

Experimental

Interventions of this group include pelvic floor exercises and behavioral therapy plus respiratory exercises for 8 weeks.

干预措施: Pelvic floor exercises and behavioral therapy (Other)

pelvic floor exercises, behavioral therapy and respiratory exercises group

Experimental

Interventions of this group include pelvic floor exercises and behavioral therapy plus respiratory exercises for 8 weeks.

干预措施: Respiratory exercises (Other)

pelvic floor exercises and behavioral therapy group

Active Comparator

Interventions of this group include pelvic floor exercises and behavioral therapy for 8 weeks.

干预措施: Pelvic floor exercises and behavioral therapy (Other)

结局指标

主要结局

Intravaginal Ejaculatation Latency Time(IELT)

时间窗: Change from pre-treatment of Intravaginal Ejaculatory Latency Time and at the end of the 8 weeks after treatment.

Intravaginal ejaculation latency time (IELT) is the time it takes to ejaculate during vaginal penetration. An intravaginal ejaculation time if less than 1 minute is defined as premature ejaculation.

次要结局

  • Assessment of the Autonomic Nervous System(Change from pre-treatment of autonomic nervous system data from elite hrv device and at the end of the 8 weeks after treatment.)
  • Pelvic Floor Muscles Contraction and Endurance Assesment(Change from pre-treatment of pelvic floor contraction and endurance with ultrasound and at the end of the 8 weeks after treatment.)

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilber Karagozoglu Coskunsu

principal investigator

Bahçeşehir University

研究点 (1)

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