Actively Recruiting

Age: 18Years +
MALE
ID06677814

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

Led by Xijing Hospital · Updated on 2024-11-07

700

Participants Needed

2

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Premature ejaculation (PE) is a common sexual dysfunction that can negatively affect quality of life and mental health, especially when anxiety disorders are also present. Researchers are working to create and test a prediction model to identify PE patients at high risk of developing anxiety disorders. This model aims to help with early treatments and improve patient care through targeted support. In this observational study, male patients diagnosed with PE will be enrolled from several clinical centers. Participants will undergo assessments including questionnaires, clinical interviews, and medical history reviews to gather data on factors that might predict anxiety disorders. Machine learning will analyze this data to build the prediction model. The model's performance will then be tested using a separate group of patients to verify its accuracy and stability. Participants will be followed for about one year, with anxiety symptoms assessed within three months after PE diagnosis. Researchers will measure the prediction model's accuracy, sensitivity, and specificity in identifying anxiety disorders. The study involves collecting detailed patient information through interviews and questionnaires. This research could lead to better personalized care for those at risk of anxiety related to PE.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Comply with the international medical premature ejaculation diagnostic criteria
  • Male individuals with a heterosexual orientation who engage in vaginal intercourse
  • Have a stable monogamous relationship
  • International Index of Erectile Function-5 scale score of 17 or higher (no or mild erectile dysfunction)
  • Informed consent given and willingness to support the study
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Sexual orientation of gay or bisexual
  • Judgment of premature ejaculation based only on masturbation or non-vaginal intercourse
  • Premature ejaculation self-assessment scale score of 8 or lower
  • Presence of diseases that may affect anxiety symptoms such as hyperthyroidism, hypothyroidism, digestive diseases, or malignant tumors
  • Use of anti-anxiety or premature ejaculation treatment drugs within the past 2 months
  • History of severe neurological diseases (e.g., epilepsy) or mental disorders such as schizophrenia or bipolar disorder
  • Poor cooperation during diagnostic interviews

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 3 months

Participants are observed to assess anxiety state within three months after diagnosis of premature ejaculation and to collect data for prediction model development and validation.

1 to 2 visits depending on cohort assignment

Long-term Monitoring

Duration - Approximately 1 year

Participants are monitored to verify the accuracy, sensitivity, and specificity of the anxiety disorder prediction model over about one year.

Periodic follow-up visits as scheduled

Trial Site Locations

Total: 2 locations

1

Xi'an Daxing Hospital affiliated to Yan'an University

Xi'an, Shaanxi, China, 710016

Actively Recruiting

2

Xijing Hospital

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

J

Jianlin Yuan, Doctor

Z

Zhaoqing Li, bachelor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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