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Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time (premature)

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic floor exercises and behavioral therapy
Respiratory exercises
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring premature ejaculation, respiratory exercises, pelvic floor muscles endurance, pelvic floor muscles strength, parasympathetic activity, behavioral therapy

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kurbaa Egitim Danısmanlık Merkezi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pelvic floor exercises, behavioral therapy and respiratory exercises group

pelvic floor exercises and behavioral therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intravaginal Ejaculatation Latency Time(IELT)
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.

Secondary Outcome Measures

Pelvic Floor Muscles Contraction and Endurance Assesment
Pelvic floor muscle contraction will be done by measuring with ultrasound the amount of bladder floor movement. 1 hour before the test, all participants will be asked to fill their bladders by consuming 600-750 ml of water within half an hour without urinating.
Assessment of the Autonomic Nervous System
Elite HRV device will attached to the index fingers of the patients in the sitting position, and data is collected and recorded for 1 minute. The expression RMSSD is used for a snapshot of the Parasympathetic branch of the Autonomic Nervous System and is the basis for your HRV score. PNN50 refers to NN50 divided by the total number of NN (R-R) intervals. NN50 is the number of consecutive pairs of NN (R-R) intervals that differ by more than 50 ms (Heathers, 2014). LF power is the efficiency of the frequency in the range of 0.04 - 0.15 Hz.

Full Information

First Posted
August 24, 2022
Last Updated
February 1, 2023
Sponsor
Bahçeşehir University
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1. Study Identification

Unique Protocol Identification Number
NCT05517694
Brief Title
Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time
Acronym
premature
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
premature ejaculation, respiratory exercises, pelvic floor muscles endurance, pelvic floor muscles strength, parasympathetic activity, behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
62 participants will randomly divided into two groups.
Masking
ParticipantOutcomes Assessor
Masking Description
The study will be double blind (both participants and assessor blinded)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pelvic floor exercises, behavioral therapy and respiratory exercises group
Arm Type
Experimental
Arm Description
Interventions of this group include pelvic floor exercises and behavioral therapy plus respiratory exercises for 8 weeks.
Arm Title
pelvic floor exercises and behavioral therapy group
Arm Type
Active Comparator
Arm Description
Interventions of this group include pelvic floor exercises and behavioral therapy for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercises and behavioral therapy
Intervention Description
Pelvic floor exercises and behavioral therapy interventions include a 4-step treatment protocol: 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 behavioral therapy, 4) the strengthening exercises of the pelvic floor muscles. 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, 8 weeks.
Intervention Type
Other
Intervention Name(s)
Respiratory exercises
Intervention Description
Pelvic floor exercises and behavioral therapy interventions include a 4-step treatment protocol: 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 behavioral therapy, 4) the strengthening exercises of the pelvic floor muscles. 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, 8 weeks. Respiratory exercises will be given 6 breaths/minute with expiration and inspiration times of 7 seconds and 3 seconds, respectively. At least 10 diaphragmatic breaths will be given in each session, 2 times a day, 7 days a week, 8 weeks.
Primary Outcome Measure Information:
Title
Intravaginal Ejaculatation Latency Time(IELT)
Description
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.
Time Frame
Change from pre-treatment of Intravaginal Ejaculatory Latency Time and at the end of the 8 weeks after treatment.
Secondary Outcome Measure Information:
Title
Pelvic Floor Muscles Contraction and Endurance Assesment
Description
Pelvic floor muscle contraction will be done by measuring with ultrasound the amount of bladder floor movement. 1 hour before the test, all participants will be asked to fill their bladders by consuming 600-750 ml of water within half an hour without urinating.
Time Frame
Change from pre-treatment of pelvic floor contraction and endurance with ultrasound and at the end of the 8 weeks after treatment.
Title
Assessment of the Autonomic Nervous System
Description
Elite HRV device will attached to the index fingers of the patients in the sitting position, and data is collected and recorded for 1 minute. The expression RMSSD is used for a snapshot of the Parasympathetic branch of the Autonomic Nervous System and is the basis for your HRV score. PNN50 refers to NN50 divided by the total number of NN (R-R) intervals. NN50 is the number of consecutive pairs of NN (R-R) intervals that differ by more than 50 ms (Heathers, 2014). LF power is the efficiency of the frequency in the range of 0.04 - 0.15 Hz.
Time Frame
Change from pre-treatment of autonomic nervous system data from elite hrv device and at the end of the 8 weeks after treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ümit Erkut, PhD(c),PT
Organizational Affiliation
Bahçeşehir University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dilber Karagozoglu Coskunsu, PhD,PT
Organizational Affiliation
Fernerbahce University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Veysel Ozden, PhD,MD
Organizational Affiliation
Bahçeşehir University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kubra Erkut, PT
Organizational Affiliation
Kurbaa Egitim Danısmanlık
Official's Role
Study Chair
Facility Information:
Facility Name
Kurbaa Egitim Danısmanlık Merkezi
City
Istanbul
ZIP/Postal Code
34183
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16934919
Citation
Porst H, Montorsi F, Rosen RC, Gaynor L, Grupe S, Alexander J. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: prevalence, comorbidities, and professional help-seeking. Eur Urol. 2007 Mar;51(3):816-23; discussion 824. doi: 10.1016/j.eururo.2006.07.004. Epub 2006 Jul 26.
Results Reference
result
PubMed Identifier
24848805
Citation
Serefoglu EC, McMahon CG, Waldinger MD, Althof SE, Shindel A, Adaikan G, Becher EF, Dean J, Giuliano F, Hellstrom WJ, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, Torres LO. An evidence-based unified definition of lifelong and acquired premature ejaculation: report of the second International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. J Sex Med. 2014 Jun;11(6):1423-41. doi: 10.1111/jsm.12524. Epub 2014 May 22.
Results Reference
result
PubMed Identifier
18391557
Citation
Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624.
Results Reference
result
PubMed Identifier
23651451
Citation
Gao J, Zhang X, Su P, Liu J, Xia L, Yang J, Shi K, Tang D, Hao Z, Zhou J, Liang C. Prevalence and factors associated with the complaint of premature ejaculation and the four premature ejaculation syndromes: a large observational study in China. J Sex Med. 2013 Jul;10(7):1874-81. doi: 10.1111/jsm.12180. Epub 2013 May 7.
Results Reference
result
PubMed Identifier
27652216
Citation
McMahon CG, Jannini EA, Serefoglu EC, Hellstrom WJ. The pathophysiology of acquired premature ejaculation. Transl Androl Urol. 2016 Aug;5(4):434-49. doi: 10.21037/tau.2016.07.06.
Results Reference
result
PubMed Identifier
26552599
Citation
Corona G, Rastrelli G, Limoncin E, Sforza A, Jannini EA, Maggi M. Interplay Between Premature Ejaculation and Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2015 Dec;12(12):2291-300. doi: 10.1111/jsm.13041. Epub 2015 Nov 9.
Results Reference
result

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Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time

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