Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time

NCT05517694 | Completed

• 1 other identifier: BahcesehirUn.
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ejaculation

Keywords

premature ejaculation; respiratory exercises; pelvic floor muscles endurance; pelvic floor muscles strength; parasympathetic activity; behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

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.

Other: Pelvic floor exercises and behavioral therapy; Other: Respiratory exercises

pelvic floor exercises and behavioral therapy group

ACTIVE COMPARATOR

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

Other: Pelvic floor exercises and behavioral therapy

Interventions

Pelvic floor exercises and behavioral therapy OTHER

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.

pelvic floor exercises and behavioral therapy group; pelvic floor exercises, behavioral therapy and respiratory exercises group

Respiratory exercises OTHER

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.

pelvic floor exercises, behavioral therapy and respiratory exercises group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Kurbaa Egitim Danısmanlık Merkezi

Istanbul, 34183, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 16934919 RESULT

• 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.

  PMID: 24848805 RESULT

• Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624.

  PMID: 18391557 RESULT

• 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.

  PMID: 23651451 RESULT

• 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.

  PMID: 27652216 RESULT

• 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.

  PMID: 26552599 RESULT

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Behavior Therapy; Breathing Exercises

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ümit Erkut, PhD(c),PT

  Bahçeşehir University

  PRINCIPAL INVESTIGATOR

• Dilber Karagozoglu Coskunsu, PhD,PT

  Fernerbahce University

  STUDY CHAIR

• Ali Veysel Ozden, PhD,MD

  Bahçeşehir University

  STUDY CHAIR

• Kubra Erkut, PT

  Kurbaa Egitim Danısmanlık

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be double blind (both participants and assessor blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 62 participants will randomly divided into two groups.

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 10, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 15, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-02

Locations

TU (1)