Clinical trial NCT05517694: Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Keywords: premature ejaculation
respiratory exercises
pelvic floor muscles endurance
pelvic floor muscles strength
parasympathetic activity
behavioral therapy
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 59
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 62 participants will randomly divided into two groups.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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. Psychological comorbidities such as depression, anxiety, and extreme stress are associated with premature ejaculation. It has been observed that pelvic and perineal muscles that have not been fully relaxed may cause premature ejaculation.

PURPOSE 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.

METHOD 62 individuals between the ages of 18-45 with premature ejaculation problems will be included in the study. Participating in the study will be randomly divided into two groups. To the 1st group (n=32), 1) awareness of the pelvic floor muscles, 2) teaching the specific contraction of the pelvic floor muscles, 3) teaching the timing of the contraction and maintenance of the pelvic floor muscles during the intercourse pre-orgasmic sensation with start stop technique, 4) the strengthening exercises of the pelvic floor muscles. A 4-step treatment protocol will be applied. Pelvic floor muscle strengthening exercises will be given for both slow-twitch and fast-twitch fibers. For slow twitch fibers, 15 repetitive exercises including 10 seconds of submaximal contraction followed by 10 seconds of relaxation, and 10 repetitive exercises including 1 second submaximal contraction followed by 1 second relaxation for fast-twitch fibers will be given 2 times a day, 3 days a week. Slow and fast twitch fiber contraction exercises will require maximum contraction of the specific pelvic floor muscles without contraction of the gluteal and abdominal and adductor muscles. In the second group (n=32), breathing exercises will be given in addition to this treatment protocol. Diaphragmatic breathing exercises will be given 6 breaths/minute, expiration and inspiration times of 7 seconds and 3 seconds, respectively, and at least 10 diaphragmatic breaths will be given in each session, 3 times a day, 8 weeks. All individuals to be included in the study will be selected, according to The International Society for Sexual Medicine (ISSM), who always or almost always ejaculate 1 minute or more before vaginal penetration. Intravaginal ejaculation time (IELT) will be evaluated for both groups before and after the application. Before the application, pelvic floor muscle strength and endurance of both groups will be evaluated by ultrasound.

Inclusion criteria for the study:

* 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

Exclusion criteria from the study:

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Intravaginal Ejaculatation Latency Time(IELT)
timeFrame: Change from pre-treatment of Intravaginal Ejaculatory Latency Time and at the end of the 8 weeks after treatment.
Secondary outcomes:
measure: Pelvic Floor Muscles Contraction and Endurance Assesment
timeFrame: Change from pre-treatment of pelvic floor contraction and endurance with ultrasound and at the end of the 8 weeks after treatment.
measure: Assessment of the Autonomic Nervous System
timeFrame: Change from pre-treatment of autonomic nervous system data from elite hrv device and at the end of the 8 weeks after treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kurbaa Egitim Danısmanlık Merkezi
Study officials:
affiliation: Bahçeşehir University
name: Ümit Erkut, PhD(c),PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Fernerbahce University
name: Dilber Karagozoglu Coskunsu, PhD,PT
role: STUDY_CHAIR
affiliation: Bahçeşehir University
name: Ali Veysel Ozden, PhD,MD
role: STUDY_CHAIR
affiliation: Kurbaa Egitim Danısmanlık
name: Kubra Erkut, PT
role: STUDY_CHAIR
References:
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