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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06677814
Enrollment
700
Registered
2024-11-07
Start date
2024-03-25
Completion date
2026-05-01
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Premature Ejaculation

Brief 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.

Interventions

None listed

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * Be informed of the purpose of this study, support this study, and complete the informed consent form

Exclusion criteria

* 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 * Suffering from diseases that may affect anxiety symptoms (hyperthyroidism/hypothyroidism, digestive diseases, malignant tumors, etc.) * Within 2 months, have taken anti-anxiety drugs and/or drugs for PE treatment * Those with a history of severe neurological diseases (such as epilepsy) and/or a history of schizophrenia, bipolar disorder, or other mental disorders * Poor cooperation during diagnostic interviews

Design outcomes

Primary

MeasureTime frameDescription
Anxiety State of patientsWithin three months after the patient is diagnosed with premature ejaculation.Use the Mini International Neuropsychiatric Interview (MINI) to conduct a structured interview with the patient to determine if they have an anxiety disorder.
Accuracy of the Prediction ModelThrough study completion, an average fo 1 yearEvaluate the accuracy of the prediction model by comparing its predictions against actual diagnoses of anxiety disorders.

Secondary

MeasureTime frameDescription
Sensitivity of the Prediction ModelThrough study completion, an average fo 1 yearAssess the model's performance in identifying patients who actually develop anxiety disorders.
Specificity of the Prediction ModelThrough study completion, an average fo 1 yearAssess the model's performance in identifying patients who do not develop anxiety disorders.

Countries

China

Contacts

Primary ContactJianlin Yuan, Doctor
jianliny@fmmu.edu.cn13609123155
Backup ContactZhaoqing Li, bachelor
lee000325@163.com17791369272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026