Premature EjaculationNCT07614854
Effect of Prostatic Urethra and Seminal Vesicle Morphometry on Ejaculation
An observational study of Premature Ejaculation and Ejaculation, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn whether the size and shape of the prostatic urethra and seminal vesicles - measured on multiparametric prostate MRI (mpMRI) - are related to premature ejaculation (PE) severity in men aged 18-55. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation, Ejaculation
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2026to 10 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: * Any major psychiatric or somatic disorder * Hormonal disorders such as hypothyroidism or hyperthyroidism * Erectile dysfunction (IIEF-15 erectile function domain score <26) * Age below 18 or above 55 years
Who may be able to join
- - Male aged 18 to 55 years
- In a stable, heterosexual, monogamous relationship with the same female partner for at least 6 months
- Normal erectile function defined as IIEF-15 erectile function domain score ≥26
- Scheduled for clinically indicated multiparametric prostate MRI due to elevated PSA or hematospermia
- Not using any medication that may affect sexual function or psychological status (e.g., SSRIs, PDE5 inhibitors)
Who cannot join
- Any major psychiatric or somatic disorder
- Hormonal disorders such as hypothyroidism or hyperthyroidism
- Erectile dysfunction (IIEF-15 erectile function domain score <26)
- Age below 18 or above 55 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, Istanbul, 34200
veysel sezgin, M.D., 90 5513895655, veyselsezgin1@gmail.com
About this study
Official title: The Effect of Prostatic Urethral and Seminal Vesicle Morphometry on Multiparametric Prostate Magnetic Resonance Imaging on Ejaculation
The goal of this observational study is to learn whether the size and shape of the prostatic urethra and seminal vesicles - measured on multiparametric prostate MRI (mpMRI) - are related to premature ejaculation (PE) severity in men aged 18-55.
The main questions it aims to answer are:
Read more
- Do men with premature ejaculation have different prostatic urethral length and angulation compared to men without PE?
- Do men with premature ejaculation have different seminal vesicle dimensions compared to men without PE?
- Do prostatic urethra and seminal vesicle measurements on mpMRI correlate with PE severity scores (PEDT) and ejaculation latency time (IELT)?
Researchers will compare men with premature ejaculation to healthy men without ejaculatory complaints to see if specific anatomical features are associated with PE severity.
Participants will:
- Undergo a multiparametric prostate MRI that is already scheduled as part of their routine medical care
- Complete validated questionnaires about ejaculation and sexual function (PEDT, PEP, IELT, IIEF-15)
- Provide a blood sample for routine hormone level measurements
Read the detailed description
Premature ejaculation (PE) is the most common male sexual dysfunction, affecting approximately 20-30% of men worldwide. Despite its high prevalence, its pathophysiology remains incompletely understood. While neurobiological and psychological factors have been extensively studied, the potential role of anatomical variations in the lower urinary tract
- specifically the prostatic urethra and seminal vesicles - has received limited attention in the literature.
The seminal vesicles play a key role in ejaculation by contributing approximately 70% of seminal fluid volume. Previous ultrasound-based studies have suggested a possible relationship between seminal vesicle size and PE severity. However, no study to date has investigated prostatic urethral and seminal vesicle morphometry using the superior spatial resolution of multiparametric prostate MRI (mpMRI) in relation to PE.
STUDY DESIGN:
Single-center, prospective, observational cohort study conducted at Başakşehir Çam ve Sakura City Hospital Urology Clinic, Istanbul, Turkey.
PARTICIPANTS:
150 men aged 18-55 years scheduled for clinically indicated mpMRI (elevated PSA or hematospermia) will be enrolled and divided into two cohorts:
- PE Group: Men meeting ISSM criteria for lifelong PE (ejaculation within ~1 minute of vaginal penetration) or acquired PE (ejaculation within ~3 minutes of vaginal penetration), with inability to delay ejaculation and negative personal consequences.
- Control Group: Healthy men without PE or any other sexual dysfunction complaint, with good ejaculatory control.
All participants must be in a stable heterosexual monogamous relationship with the same partner for at least 6 months and have normal erectile function (IIEF-15 erectile function domain score ≥26). Men using medications that may affect sexual function (SSRIs, PDE5 inhibitors) or those with hormonal disorders, major psychiatric conditions, or erectile dysfunction will be excluded.
MRI MORPHOMETRIC PARAMETERS:
The following measurements will be obtained from existing mpMRI images by the study urologists, without need for additional radiology support:
- Prostatic urethral length (mm)
- Prostatic urethral angulation (degrees)
- Prostate posterior-anterior and lateral dimensions (mm)
- Seminal vesicle anterior-posterior length (mm)
- Seminal vesicle superior-anterior length (mm)
- Seminal vesicle size to prostatic urethra size ratio
- Prostate size to prostatic urethra size ratio
OUTCOME ASSESSMENTS:
- Premature Ejaculation Diagnostic Tool (PEDT): range 0-20, higher scores indicate greater PE severity
- Premature Ejaculation Profile (PEP): assesses ejaculatory control, distress, satisfaction, and interpersonal difficulty
- Intravaginal Ejaculation Latency Time (IELT): recorded in seconds, lower values indicate greater PE severity
- International Index of Erectile Function (IIEF-15): used to confirm normal erectile function and exclude erectile dysfunction
- Serum hormone levels: total testosterone, TSH, prolactin
- Demographic data: age, sexual abstinence duration
STATISTICAL ANALYSIS:
Continuous variables will be tested for normality using Shapiro-Wilk and Kolmogorov-Smirnov tests and expressed as mean ± standard deviation or median (min-max) accordingly. Group comparisons will be performed using Student t-test or Mann-Whitney U test for continuous variables and Chi-square or Fisher exact test for categorical variables.
Correlations between mpMRI morphometric parameters and PE severity (PEDT score, IELT) will be assessed using Pearson or Spearman correlation analyses. The primary analysis will use multiple linear regression to identify independent morphometric predictors of PE severity, with age, sexual abstinence duration, and hormone levels included as covariates. Multicollinearity will be assessed using variance inflation factor (VIF) and tolerance values.
Sample size was calculated using G*Power software (version 3.1.9.7) with medium effect size (f²=0.15), two-sided α=0.05, and 90% power, yielding a minimum of 123 participants. 150 participants will be enrolled to account for potential dropout.
All statistical analyses will be performed using IBM SPSS Statistics (version 30.0.0.0). Statistical significance will be set at p<0.05 (two-tailed).
No additional procedures beyond the clinically indicated mpMRI are required. The study poses no additional risk to participants.
- Conditions
- Premature Ejaculation, Ejaculation
- Keywords
- Prostatic Urethra, seminal vesicle, morphometry
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premature Ejaculation | Men aged 18-55 years meeting ISSM criteria for lifelong or acquired premature ejaculation. Lifelong PE is defined as ejaculation occurring within approximately 1 minute of vaginal penetration since first sexual experience. Acquired PE is defined as ejaculation within approximately 3 minutes of vaginal penetration. All participants must have an inability to delay ejaculation and report negative personal consequences. Participants must have normal erectile function (IIEF-15 ≥26), be in a stable heterosexual monogamous relationship for at least 6 months, and have a clinically indicated mpMRI scheduled. | |
| Control Group | Healthy men aged 18-55 years without premature ejaculation or any other sexual dysfunction complaint. Participants must have good ejaculatory control, normal erectile function (IIEF-15 ≥26), and be in a stable heterosexual monogamous relationship for at least 6 months. Participants must have a clinically indicated mpMRI scheduled due to elevated PSA or hematospermia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Prostatic Urethral Length and Premature Ejaculation Severity
Pearson or Spearman correlation between prostatic urethral length measured on mpMRI (mm) and PEDT score. Higher PEDT score indicates greater PE severity (range 0-20).
Measured: At enrollment (single time point)
Correlation Between Seminal Vesicle Dimensions and Premature Ejaculation Severity
Pearson or Spearman correlation between seminal vesicle anterior-posterior length and superior-anterior length measured on mpMRI (mm) and PEDT score. Higher PEDT score indicates greater PE severity (range 0-20).
Measured: At enrollment (single time point)
Correlation Between Prostatic Urethral Angulation and Intravaginal Ejaculation Latency Time
Pearson or Spearman correlation between prostatic urethral angulation measured on mpMRI (degrees) and IELT (seconds). Lower IELT indicates greater PE severity.
Measured: At enrollment (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SEZGIN, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614854
- Sponsor's protocol ID
- KAEK-11/24.12.2025.472
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forbes CM, Flannigan R, Paduch DA. Perineal Ultrasound: a Review in the Context of Ejaculatory Dysfunction. Sex Med Rev. 2018 Jul;6(3):419-428. doi: 10.1016/j.sxmr.2017.12.005. Epub 2018 Feb 17.
PubMed 29463441Serefoglu 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. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27.
PubMed 25356301
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prostatic Urethral and Seminal Vesicle Morphometry on Multiparametric Prostate Magnetic Resonance Imaging on Ejaculation
- ClinicalTrials.gov ID
- NCT07614854
- Acronym / sponsor ID
- KAEK-11/24.12.2025.472
- Conditions
- Premature Ejaculation, Ejaculation
- Keywords
- Prostatic Urethra, seminal vesicle, morphometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn whether the size and shape of the prostatic urethra and seminal vesicles - measured on multiparametric prostate MRI (mpMRI) - are related to premature ejaculation (PE) severity in men aged 18-55.
The main questions it aims to answer are:
- Do men with premature ejaculation have different prostatic urethral length and angulation compared to men without PE?
- Do men with premature ejaculation have different seminal vesicle dimensions compared to men without PE?
- Do prostatic urethra and seminal vesicle measurements on mpMRI correlate with PE severity scores (PEDT) and ejaculation latency time (IELT)?
Researchers will compare men with premature ejaculation to healthy men without ejaculatory complaints to see if specific anatomical features are associated with PE severity.
Participants will:
- Undergo a multiparametric prostate MRI that is already scheduled as part of their routine medical care
- Complete validated questionnaires about ejaculation and sexual function (PEDT, PEP, IELT, IIEF-15)
- Provide a blood sample for routine hormone level measurements
Detailed description
Premature ejaculation (PE) is the most common male sexual dysfunction, affecting approximately 20-30% of men worldwide. Despite its high prevalence, its pathophysiology remains incompletely understood. While neurobiological and psychological factors have been extensively studied, the potential role of anatomical variations in the lower urinary tract
- specifically the prostatic urethra and seminal vesicles - has received limited attention in the literature.
The seminal vesicles play a key role in ejaculation by contributing approximately 70% of seminal fluid volume. Previous ultrasound-based studies have suggested a possible relationship between seminal vesicle size and PE severity. However, no study to date has investigated prostatic urethral and seminal vesicle morphometry using the superior spatial resolution of multiparametric prostate MRI (mpMRI) in relation to PE.
STUDY DESIGN:
Single-center, prospective, observational cohort study conducted at Başakşehir Çam ve Sakura City Hospital Urology Clinic, Istanbul, Turkey.
PARTICIPANTS:
150 men aged 18-55 years scheduled for clinically indicated mpMRI (elevated PSA or hematospermia) will be enrolled and divided into two cohorts:
- PE Group: Men meeting ISSM criteria for lifelong PE (ejaculation within ~1 minute of vaginal penetration) or acquired PE (ejaculation within ~3 minutes of vaginal penetration), with inability to delay ejaculation and negative personal consequences.
- Control Group: Healthy men without PE or any other sexual dysfunction complaint, with good ejaculatory control.
All participants must be in a stable heterosexual monogamous relationship with the same partner for at least 6 months and have normal erectile function (IIEF-15 erectile function domain score ≥26). Men using medications that may affect sexual function (SSRIs, PDE5 inhibitors) or those with hormonal disorders, major psychiatric conditions, or erectile dysfunction will be excluded.
MRI MORPHOMETRIC PARAMETERS:
The following measurements will be obtained from existing mpMRI images by the study urologists, without need for additional radiology support:
- Prostatic urethral length (mm)
- Prostatic urethral angulation (degrees)
- Prostate posterior-anterior and lateral dimensions (mm)
- Seminal vesicle anterior-posterior length (mm)
- Seminal vesicle superior-anterior length (mm)
- Seminal vesicle size to prostatic urethra size ratio
- Prostate size to prostatic urethra size ratio
OUTCOME ASSESSMENTS:
- Premature Ejaculation Diagnostic Tool (PEDT): range 0-20, higher scores indicate greater PE severity
- Premature Ejaculation Profile (PEP): assesses ejaculatory control, distress, satisfaction, and interpersonal difficulty
- Intravaginal Ejaculation Latency Time (IELT): recorded in seconds, lower values indicate greater PE severity
- International Index of Erectile Function (IIEF-15): used to confirm normal erectile function and exclude erectile dysfunction
- Serum hormone levels: total testosterone, TSH, prolactin
- Demographic data: age, sexual abstinence duration
STATISTICAL ANALYSIS:
Continuous variables will be tested for normality using Shapiro-Wilk and Kolmogorov-Smirnov tests and expressed as mean ± standard deviation or median (min-max) accordingly. Group comparisons will be performed using Student t-test or Mann-Whitney U test for continuous variables and Chi-square or Fisher exact test for categorical variables.
Correlations between mpMRI morphometric parameters and PE severity (PEDT score, IELT) will be assessed using Pearson or Spearman correlation analyses. The primary analysis will use multiple linear regression to identify independent morphometric predictors of PE severity, with age, sexual abstinence duration, and hormone levels included as covariates. Multicollinearity will be assessed using variance inflation factor (VIF) and tolerance values.
Sample size was calculated using G*Power software (version 3.1.9.7) with medium effect size (f²=0.15), two-sided α=0.05, and 90% power, yielding a minimum of 123 participants. 150 participants will be enrolled to account for potential dropout.
All statistical analyses will be performed using IBM SPSS Statistics (version 30.0.0.0). Statistical significance will be set at p<0.05 (two-tailed).
No additional procedures beyond the clinically indicated mpMRI are required. The study poses no additional risk to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature Ejaculation | – | –Men aged 18-55 years meeting ISSM criteria for lifelong or acquired premature ejaculation. Lifelong PE is defined as ejaculation occurring within approximately 1 minute of vaginal penetration since first sexual experience. Acquired PE is defined as ejaculation within approximately 3 minutes of vaginal penetration. All participants must have an inability to delay ejaculation and report negative personal consequences. Participants must have normal erectile function (IIEF-15 ≥26), be in a stable heterosexual monogamous relationship for at least 6 months, and have a clinically indicated mpMRI scheduled. |
| Control Group | – | –Healthy men aged 18-55 years without premature ejaculation or any other sexual dysfunction complaint. Participants must have good ejaculatory control, normal erectile function (IIEF-15 ≥26), and be in a stable heterosexual monogamous relationship for at least 6 months. Participants must have a clinically indicated mpMRI scheduled due to elevated PSA or hematospermia. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Any major psychiatric or somatic disorder * Hormonal disorders such as hypothyroidism or hyperthyroidism * Erectile dysfunction (IIEF-15 erectile function domain score <26) * Age below 18 or above 55 years
Key inclusion criteria (5 listed)
- - Male aged 18 to 55 years
- In a stable, heterosexual, monogamous relationship with the same female partner for at least 6 months
- Normal erectile function defined as IIEF-15 erectile function domain score ≥26
- Scheduled for clinically indicated multiparametric prostate MRI due to elevated PSA or hematospermia
- Not using any medication that may affect sexual function or psychological status (e.g., SSRIs, PDE5 inhibitors)
Key exclusion criteria (4 listed)
- Any major psychiatric or somatic disorder
- Hormonal disorders such as hypothyroidism or hyperthyroidism
- Erectile dysfunction (IIEF-15 erectile function domain score <26)
- Age below 18 or above 55 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Prostatic Urethral Length and Premature Ejaculation Severity
Time frame: At enrollment (single time point)
Pearson or Spearman correlation between prostatic urethral length measured on mpMRI (mm) and PEDT score. Higher PEDT score indicates greater PE severity (range 0-20).
Correlation Between Seminal Vesicle Dimensions and Premature Ejaculation Severity
Time frame: At enrollment (single time point)
Pearson or Spearman correlation between seminal vesicle anterior-posterior length and superior-anterior length measured on mpMRI (mm) and PEDT score. Higher PEDT score indicates greater PE severity (range 0-20).
Correlation Between Prostatic Urethral Angulation and Intravaginal Ejaculation Latency Time
Time frame: At enrollment (single time point)
Pearson or Spearman correlation between prostatic urethral angulation measured on mpMRI (degrees) and IELT (seconds). Lower IELT indicates greater PE severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 29463441Forbes CM, Flannigan R, Paduch DA. Perineal Ultrasound: a Review in the Context of Ejaculatory Dysfunction. Sex Med Rev. 2018 Jul;6(3):419-428. doi: 10.1016/j.sxmr.2017.12.005. Epub 2018 Feb 17.
- Background: PubMed 25356301Serefoglu 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. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation and Ejaculation, run by Başakşehir Çam & Sakura City Hospital 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VEYSEL SEZGİN, MD (+905513895655, veyselsezgin1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Prostatic Urethral Length and Premature Ejaculation Severity (time frame: At enrollment (single time point)). The study lists 3 primary outcomes in all. 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 NCT07614854, which also lists 2 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 3 Jun 2026.