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Effect of Prostatic Urethra and Seminal Vesicle Morphometry on Ejaculation

30 de mayo de 2026 actualizado por: SEZGIN, Başakşehir Çam & Sakura City Hospital

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:

  • 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

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

150

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Istanbul
      • Istanbul, Istanbul, Turquía (Türkiye), 34200
        • Başakşehir Çam and Sakura City Hospital, Department of Urology
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

  • 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

Descripción

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:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation Between Prostatic Urethral Length and Premature Ejaculation Severity
Periodo de tiempo: 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).
At enrollment (single time point)
Correlation Between Seminal Vesicle Dimensions and Premature Ejaculation Severity
Periodo de tiempo: 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).
At enrollment (single time point)
Correlation Between Prostatic Urethral Angulation and Intravaginal Ejaculation Latency Time
Periodo de tiempo: 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.
At enrollment (single time point)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

10 de mayo de 2026

Finalización primaria (Estimado)

10 de agosto de 2026

Finalización del estudio (Estimado)

10 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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