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NCT06677814
Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients
trial in Premature Ejaculation in 700 participants. Currently enrolling.
25 March 2025
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 700 |
| Start date | 25 March 2024 |
| Primary completion | 25 March 2025 |
| Estimated completion | 1 May 2026 |
| Sites | 2 locations across China |
Conditions studied
- Premature Ejaculation — all drugs for Premature Ejaculation →
- Anxiety — all drugs for Anxiety →
Sponsor
Xijing Hospital
Who can join
18 and older, male only, with Premature Ejaculation or Anxiety. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06677814 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital
- Last refreshed: 7 November 2024
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