Actively Recruiting

Age: 18Years +
MALE
NCT06677814

Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients

Led by Xijing Hospital · Updated on 2024-11-07

700

Participants Needed

2

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Premature ejaculation (PE) is a common sexual dysfunction that can significantly impact the quality of life and psychological well-being of affected individuals. Anxiety disorders, often comorbid with PE, exacerbate symptoms and complicate treatment outcomes. There is a critical need for a reliable prediction model to identify patients at risk of developing anxiety disorders associated with PE. Objective: The primary aim of this study is to develop and validate a predictive model that accurately identifies premature ejaculation patients who are at high risk of developing anxiety disorders. The model will be designed to facilitate early intervention strategies and improve patient outcomes. Methods: This prospective observational study will enroll male patients diagnosed with PE from multiple clinical centers. Participants will undergo comprehensive assessments including validated questionnaires, clinical interviews, and medical history reviews to collect baseline data on potential predictors of anxiety disorders. Machine learning algorithms will be utilized to analyze the collected data and derive a predictive model. External validation will be conducted using a separate cohort of patients not involved in the initial model development phase. Outcome Measures: The primary outcome measure will be the accuracy of the predictive model in identifying patients who subsequently develop anxiety disorders within a predefined follow-up period. Secondary outcomes include evaluating the model's sensitivity, specificity, positive predictive value, and negative predictive value. Significance: Successful development and validation of this prediction model could lead to improved patient care through targeted interventions and personalized treatment plans for those at risk of anxiety disorders related to PE. This research may also contribute to a better understanding of the complex interplay between sexual dysfunction and mental health.

CONDITIONS

Official Title

Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the international medical criteria for premature ejaculation diagnosis
  • Identify as heterosexual and engage in vaginal intercourse
  • Be in a stable, monogamous relationship
  • Have an International Index of Erectile Function-5 score of 17 points or higher
  • Understand the study purpose, agree to participate, and sign informed consent
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Identify as gay or bisexual
  • Judgment of premature ejaculation based only on masturbation or non-vaginal intercourse
  • Premature ejaculation self-assessment scale score of 8 points or lower
  • Have diseases that may affect anxiety symptoms such as hyperthyroidism, hypothyroidism, digestive diseases, or malignant tumors
  • Have taken anti-anxiety or premature ejaculation drugs within the past 2 months
  • History of severe neurological diseases like epilepsy or mental disorders such as schizophrenia or bipolar disorder
  • Poor cooperation during diagnostic interviews

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Xi'an Daxing Hospital affiliated to Yan'an University

Xi'an, Shaanxi, China, 710016

Actively Recruiting

2

Xijing Hospital

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

J

Jianlin Yuan, Doctor

CONTACT

Z

Zhaoqing Li, bachelor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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