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Premature EjaculationprematureNCT05517694

Effect of Respiratory Exercises On The Intravaginal Ejaculation Latency Time

A study testing Pelvic floor exercises and behavioral therapy and Respiratory exercises in people with Premature Ejaculation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 45 years, men only
Conditions the study is for
Premature Ejaculation
What is being tested?
Pelvic floor exercises and behavioral therapy and Respiratory exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jan 2022to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 45 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kurbaa Egitim Danısmanlık Merkezi

    Istanbul, 34183

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Read the 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
Being tested
Pelvic floor exercises and behavioral therapy, Respiratory exercises
Keywords
premature ejaculation, respiratory exercises, pelvic floor muscles endurance, pelvic floor muscles strength, parasympathetic activity, behavioral therapy
Medical subject headings
Premature Ejaculation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pelvic floor exercises and behavioral therapyOther

    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 exercisesOther

    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.

Study groups in NCT05517694
Study groupRoleWhat they receive
pelvic floor exercises, behavioral therapy and respiratory exercises groupExperimentalInterventions of this group include pelvic floor exercises and behavioral therapy plus respiratory exercises for 8 weeks.
Receives: Other: Pelvic floor exercises and behavioral therapy; Other: Respiratory exercises
pelvic floor exercises and behavioral therapy groupActive comparatorInterventions of this group include pelvic floor exercises and behavioral therapy for 8 weeks.
Receives: Other: Pelvic floor exercises and behavioral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. 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.

    Measured: Change from pre-treatment of pelvic floor contraction and endurance with ultrasound and at the end of the 8 weeks after treatment.

  2. 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.

    Measured: Change from pre-treatment of autonomic nervous system data from elite hrv device and at the end of the 8 weeks after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start10 Jan 2022
  3. Primary completion5 Jan 2023
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
62 participants will randomly divided into two groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05517694
Sponsor's protocol ID
BahcesehirUn.
Acronym
premature
Status last verified
Feb 2023
First submitted
24 Aug 2022
Last updated
2 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 16934919
  • 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.

    PubMed 24848805
  • Waldinger MD. Recent advances in the classification, neurobiology and treatment of premature ejaculation. Adv Psychosom Med. 2008;29:50-69. doi: 10.1159/000126624.

    PubMed 18391557
  • 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.

    PubMed 23651451
  • 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.

    PubMed 27652216
  • 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.

    PubMed 26552599

Questions about this trial

What is this clinical trial studying?

A study testing Pelvic floor exercises and behavioral therapy and Respiratory exercises in people with Premature Ejaculation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intravaginal Ejaculatation Latency Time(IELT) (time frame: Change from pre-treatment of Intravaginal Ejaculatory Latency Time and at the end of the 8 weeks after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05517694, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.

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