NCT06677814 Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients
| NCT ID | NCT06677814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Premature Ejaculation |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2025-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2024-03-25 with a primary completion date of 2025-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06677814 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Premature Ejaculation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06677814 currently recruiting?
Yes, NCT06677814 is actively recruiting participants. Contact the research team at jianliny@fmmu.edu.cn for enrollment information.
Where is the NCT06677814 trial being conducted?
This trial is being conducted at Xi'an, China, Xi'an, China.
Who is sponsoring the NCT06677814 clinical trial?
NCT06677814 is sponsored by Xijing Hospital. The trial plans to enroll 700 participants.