- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07783958
Male Sexual Function and Sexual Quality of Life in Polygamous Versus Monogamous Marriages
Sexual Function and Sexual Quality of Life Among Egyptian Men in Polygamous and Monogamous Marriages: A Web-Based Comparative Cross-Sectional Survey
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sexual function and sexual quality of life are influenced by biological, psychological, social, and relationship-related factors. Marital structure may be associated with differences in sexual function, sexual satisfaction, psychological distress, and quality of life; however, evidence among Egyptian men is limited.
This study will use an anonymous Arabic-language web-based questionnaire to compare married Egyptian men in monogamous and polygamous marriages. Participants will be recruited from different Egyptian governorates through online dissemination of the survey. Before completing the questionnaire, participants will review the study information sheet and provide electronic informed consent.
The questionnaire will collect sociodemographic, clinical, lifestyle, sexual, psychological, and relationship-related information. Sexual function will be assessed using the Arabic version of the Sexual Health Inventory for Men/Sexual Health Inventory for Men-5 (SHIM/IIEF-5). Sexual quality of life will be assessed using the Sexual Quality of Life-Male questionnaire. Depression, anxiety, and stress will be assessed using the Depression Anxiety Stress Scales-21. Marital satisfaction and relationship satisfaction will be assessed using predefined Likert-type questions.
The monogamous group will include men currently married to one wife. The polygamous group will include men currently married to two or more wives. Participants will be analyzed according to marital structure, and additional descriptive analyses may be performed according to the number of wives among polygamous participants.
The primary analysis will compare SHIM scores and the proportion of participants with impaired sexual function between the two marital groups. Secondary analyses will compare sexual quality of life, psychological status, marital satisfaction, and other clinical and sociodemographic variables. Multivariable regression models will be used to assess whether marital structure is independently associated with impaired sexual function or poor sexual quality of life after adjustment for relevant confounding factors.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Abul-fotouh Ahmed, MD
- Número de teléfono: +201001066756
- Correo electrónico: abulfotouhahmed@yahoo.com
Ubicaciones de estudio
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Cairo, Egipto
- Reclutamiento
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
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Contacto:
- Abul-fotouh Ahmed
- Número de teléfono: +201001066756
- Correo electrónico: abulfotouhahmed@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Egyptian males aged 18 years or older.
- Currently married at the time of questionnaire completion.
- Currently in either a monogamous marriage, defined as marriage to one wife, or a polygamous marriage, defined as marriage to two or more wives.
- Able to read and understand Arabic.
- Willing to complete the anonymous online questionnaire.
- Able to provide electronic informed consent before accessing the questionnaire
Exclusion Criteria:
- Unmarried, divorced, or widowed individuals.
- Individuals who do not provide electronic informed consent.
- Incomplete questionnaire responses that do not contain the primary outcome measure.
- Duplicate or clearly invalid questionnaire responses.
- Self-reported major psychiatric illness or neurological disease that substantially affects sexual function.
- Participants receiving active treatment that substantially affects sexual function, unless the treatment can be documented and appropriately considered in the statistical analysis.
- Individuals unable to read or understand Arabic.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Monogamous marriage
Egyptian men aged 18 years or older who are currently married to one wife and complete the anonymous online questionnaire.
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Existing marital structure consisting of one current wife at the time of questionnaire completion.
This is an observational exposure and is not assigned, modified, or administered by the study team.
Participants in this exposure group will complete the same anonymous Arabic-language questionnaire as participants in the polygamous-marriage group.
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Polygamous marriage
Egyptian men aged 18 years or older who are currently married to two or more wives and complete the anonymous online questionnaire.
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Existing marital structure consisting of two or more current wives at the time of questionnaire completion.
This is an observational exposure and is not assigned, modified, or administered by the study team.
Participants in this exposure group will complete the same anonymous Arabic-language questionnaire as participants in the monogamous-marriage group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sexual function score measured by the Sexual Health Inventory for Men
Periodo de tiempo: Baseline (single assessment at questionnaire completion)
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Sexual function will be assessed using the five-item Sexual Health Inventory for Men, also known as the International Index of Erectile Function-5 (SHIM/IIEF-5).
Scores range from 5 to 25, with higher scores indicating better erectile function.
The mean or median SHIM score will be compared between men in monogamous and polygamous marriages.
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Baseline (single assessment at questionnaire completion)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with impaired sexual function
Periodo de tiempo: Baseline (single assessment at questionnaire completion)
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Impaired sexual function will be defined as a SHIM/IIEF-5 score of 21 or less.
The outcome will be reported as the number and percentage of participants with impaired sexual function in each marital-structure group.
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Baseline (single assessment at questionnaire completion)
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Sexual Quality of Life-Male questionnaire score
Periodo de tiempo: Baseline (single assessment at questionnaire completion)
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Sexual quality of life will be assessed using the Sexual Quality of Life-Male questionnaire.
The total score will be reported according to the scoring system of the validated questionnaire, with higher scores indicating better sexual quality of life if applicable to the selected version.
Scores will be compared between monogamous and polygamous marriage groups.
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Baseline (single assessment at questionnaire completion)
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Relationship satisfaction score
Periodo de tiempo: Baseline (single assessment at questionnaire completion)
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Relationship satisfaction will be assessed using predefined Likert-type questions regarding satisfaction with the marital relationship.
Scores will be summarized and compared between monogamous and polygamous marriage groups, with higher scores indicating greater satisfaction.
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Baseline (single assessment at questionnaire completion)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Abul-fotouh Ahmed, MD, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UroAzhar_11_026
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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