🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06677814
Recruiting Observational

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

NCT06677814 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Observational
Started
2024-03-25
Last updated
2024-11-07

Condition(s) studied

Premature EjaculationAnxiety

Study 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
MALE
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Xi'an Daxing Hospital affiliated to Yan'an University Xi'an Shaanxi Recruiting
Xijing Hospital Xi'an Shaanxi Recruiting

More Xijing Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06677814 on ClinicalTrials.gov ↗ ← All trials in China