NCT07614854

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
May 2026Aug 2026

Study Start

First participant enrolled

May 10, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 22, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Prostatic Urethraseminal vesiclemorphometry

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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.

    At enrollment (single time point)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • \- 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital, Department of Urology

Istanbul, Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 29463441BACKGROUND
  • 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.

    PMID: 25356301BACKGROUND

Related Links

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

VEYSEL SEZGİN, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD VEYSEL SEZGİN

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

August 10, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations