- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07614854
Effect of Prostatic Urethra and Seminal Vesicle Morphometry on Ejaculation
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: VEYSEL SEZGİN, MD
- 전화번호: +905513895655
- 이메일: veyselsezgin1@gmail.com
연구 장소
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Istanbul
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Istanbul, Istanbul, 터키 (Türkiye), 34200
- Başakşehir Çam and Sakura City Hospital, Department of Urology
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연락하다:
- veysel sezgin, M.D.
- 전화번호: 90 5513895655
- 이메일: veyselsezgin1@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
- 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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation Between Prostatic Urethral Length and Premature Ejaculation Severity
기간: At enrollment (single time point)
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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).
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At enrollment (single time point)
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Correlation Between Seminal Vesicle Dimensions and Premature Ejaculation Severity
기간: At enrollment (single time point)
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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).
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At enrollment (single time point)
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Correlation Between Prostatic Urethral Angulation and Intravaginal Ejaculation Latency Time
기간: At enrollment (single time point)
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Pearson or Spearman correlation between prostatic urethral angulation measured on mpMRI (degrees) and IELT (seconds).
Lower IELT indicates greater PE severity.
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At enrollment (single time point)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KAEK-11/24.12.2025.472
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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