Pelvic Floor Therapies for Lifelong Premature Ejaculation
NCT07627438
Ejaculatory Dysfunction, Genital Diseases
Tanta, Egypt
View Trial DetailsNCT Number: NCT06677814
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.
Interested in participating?
Request Info18 year and older
Male
Observational
Xi'an Daxing Hospital affiliated to Yan'an University, Xi'an, Shaanxi, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Through study completion, an average fo 1 year
Assess the model's performance in identifying patients who actually develop anxiety disorders.
Time frame: Through study completion, an average fo 1 year
Assess the model's performance in identifying patients who do not develop anxiety disorders.
Contact information is provided by the study sponsor or research team.
Jianlin Yuan, Doctor
CONTACT
Zhaoqing Li, bachelor
CONTACT
Xijing Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07627438
Ejaculatory Dysfunction, Genital Diseases
Tanta, Egypt
View Trial DetailsNCT07442396
Ejaculatory Dysfunction, Erectile Dysfunction
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07434271
Ejaculatory Dysfunction, Genital Diseases
Botany, New South Wales, Australia
View Trial DetailsNCT06425211
Asthenia, Ejaculatory Dysfunction
Bogotá, Cundinamarca, Colombia
View Trial Details