Premature EjaculationNCT06677814
Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients
An observational study of Premature Ejaculation and Anxiety, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Premature Ejaculation, Anxiety
- How many people
- 700 participants
- Where
- 2 sitesChina
- Study dates
- 25 Mar 2024to 1 May 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xi'an Daxing Hospital affiliated to Yan'an University
Xi'an, Shaanxi, 710016
Ming Gao, Doctor, 18092333810, gaoming516@163.com
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jianlin Yuan, Doctor, 13609123155, jianliny@fmmu.edu.cn
Zhaoqing Li, bachelor, lee000325@163.com
About this study
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.
Read more
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.
- Conditions
- Premature Ejaculation, Anxiety
- Medical subject headings
- Premature Ejaculation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | 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. | |
| Validation cohort | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average fo 1 year
Secondary outcomes (2)
Sensitivity of the Prediction Model
Assess the model's performance in identifying patients who actually develop anxiety disorders.
Measured: 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.
Measured: Through study completion, an average fo 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677814
- Sponsor's protocol ID
- KY 20212177-F-1
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Anxiety Disorder Prediction Model for Premature Ejaculation Patients
- ClinicalTrials.gov ID
- NCT06677814
- Acronym / sponsor ID
- KY 20212177-F-1
- Conditions
- Premature Ejaculation, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | –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. |
| Validation cohort | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety State of patients
Time frame: Within three months after the patient is diagnosed with premature ejaculation.
Use the Mini International Neuropsychiatric Interview (MINI) to conduct a structured interview with the patient to determine if they have an anxiety disorder.
Accuracy of the Prediction Model
Time frame: Through study completion, an average fo 1 year
Evaluate the accuracy of the prediction model by comparing its predictions against actual diagnoses of anxiety disorders.
2 secondary outcomes
Sensitivity of the Prediction Model
Time frame: Through study completion, an average fo 1 year
Specificity of the Prediction Model
Time frame: Through study completion, an average fo 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation and Anxiety, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianlin Yuan, Doctor (13609123155, jianliny@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety State of patients (time frame: Within three months after the patient is diagnosed with premature ejaculation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.