Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorXijing Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Comply with the international medical premature ejaculation diagnostic criteria
Individuals with a "heterosexual" orientation who engage in vaginal intercourse
Having a stable relationship with "monogamy"
The International Index of Erectile Function-5 scale is ≥17 points, indicating that the patient has no erectile dysfunction or only mild erectile dysfunction
Disqualifiers
Minors under the age of 18
Individuals with a sexual orientation of "gay" or "bisexual"
The judgment of "ejaculation too fast" is based only on masturbation or non-vaginal sexual intercourse
The score of the premature ejaculation self-assessment scale is ≤8 points
Trial population
Participants for this study will be male patients diagnosed with premature ejaculation (PE). Sample Size： Approximately 700 patients are expected to be recruited for this study. The sample size was determined based on previous studies and statistical calculations to ensure adequate statistical power. Recruitment Sites： Participants will be recruited from four tertiary hospitals within the country.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
700 Participants
are grouped into 2 trial groupsGroup A: Training cohort
Group B: Validation cohort
Trial outcomes
Primary outcomes
1
Anxiety State of patients
Use the Mini International Neuropsychiatric Interview (MINI) to conduct a structured interview with the patient to determine if they have an anxiety disorder.
Time frame
Within three months after the patient is diagnosed with premature ejaculation.2
Accuracy of the Prediction Model
Evaluate the accuracy of the prediction model by comparing its predictions against actual diagnoses of anxiety disorders.
Time frame
Through study completion, an average fo 1 yearSecondary outcomes
1
Sensitivity of the Prediction Model
Assess the model's performance in identifying patients who actually develop anxiety disorders.
Time frame
Through study completion, an average fo 1 year2
Specificity of the Prediction Model
Assess the model's performance in identifying patients who do not develop anxiety disorders.
Time frame
Through study completion, an average fo 1 yearSponsors and contacts
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Source ClinicalTrials.gov