An observational study in Premature Ejaculation and Anxiety, sponsored by Xijing Hospital. Recruiting at 2 sites in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by Xijing Hospital · Observational
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's planned enrollment of 700 is above the median of 600 across 17 observational studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort data will be used to screen for independent risk factors for anxiety disorders in patients with premature ejaculation and to initially construct a risk prediction model.
This cohort data will be used to verify the performance and stability of the risk prediction model to ensure the promotion and use of the model.
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.
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 year
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 year
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 year
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