Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, 34200, Turkey (Türkiye)
NCT Number: NCT07614854
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
Trial opening soon.
Get Notified18 year–55 year
Male
Observational
Istanbul, 34200, Turkey (Türkiye)
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
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:
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:
OUTCOME ASSESSMENTS:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Başakşehir Çam & Sakura City Hospital
Other Gov
The Effect of Prostatic Urethral and Seminal Vesicle Morphometry on Multiparametric Prostate Magnetic Resonance Imaging on Ejaculation
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