RecruitingNCT06677814

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


Sponsor

Xijing Hospital

Enrollment

700 participants

Start Date

Mar 25, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops and validates a tool to predict which men with premature ejaculation are also likely to have anxiety disorder. Early identification could help ensure these patients receive mental health support alongside sexual health treatment. **You may be eligible if...** - You meet the international diagnostic criteria for premature ejaculation - You are in a stable, monogamous heterosexual relationship and have vaginal intercourse - Your erectile function is adequate (score of 17 or higher on the standard questionnaire) - You are willing to complete questionnaires and assessments **You may NOT be eligible if...** - You do not meet the criteria for premature ejaculation - You have severe erectile dysfunction - You have previously diagnosed anxiety disorder or are currently being treated for it - You are unwilling to complete the study assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Xi'an Daxing Hospital affiliated to Yan'an University

Xi'an, Shaanxi, China

Xijing Hospital

Xi'an, Shaanxi, China

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NCT06677814


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