ClinicalTrials.gg
Not yet recruitingNCT07614854Updated Jun 3, 2026

Effect of Prostatic Urethra and Seminal Vesicle Morphometry on Ejaculation

An observational study in Premature Ejaculation and Ejaculation, sponsored by Başakşehir Çam & Sakura City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Başakşehir Çam & Sakura City Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 55 Years
Sex
Male
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Study 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.

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
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.

02

Conditions studied

  • Premature Ejaculation
  • Ejaculation

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Keywords

  • Prostatic Urethra
  • seminal vesicle
  • morphometry
03

In context

Premature Ejaculation

106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.

This study's planned enrollment of 150 is below the median of 600 across 17 observational studies indexed under Premature Ejaculation.

Browse Premature Ejaculation studies →

Lead sponsor

Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: At enrollment (single time point)

  2. 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).

    Time frame: At enrollment (single time point)

  3. 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.

    Time frame: At enrollment (single time point)

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Study locations

1 site
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References and documents

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 29463441 ↗
  • 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. Sex Med. 2014 Jun;2(2):41-59. doi: 10.1002/sm2.27. PubMed 25356301 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07614854
Responsible party
SEZGIN (MD VEYSEL SEZGİN, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
May 29, 2026
Start date
May 10, 2026 (estimated)
Primary completion
Aug 10, 2026 (estimated)
Completion
Aug 10, 2026 (estimated)
Last update
Jun 3, 2026

Study contacts

VEYSEL SEZGİN, MD
Contact
veyselsezgin1@gmail.com
+905513895655

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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