- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Abul-fotouh Ahmed, MD
- Número de telefone: +201001066756
- E-mail: abulfotouhahmed@yahoo.com
Locais de estudo
-
-
-
Cairo, Egito
- Recrutamento
- Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University
-
Contato:
- Abul-fotouh Ahmed
- Número de telefone: +201001066756
- E-mail: abulfotouhahmed@yahoo.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Monogamous marriage
Egyptian men aged 18 years or older who are currently married to one wife and complete the anonymous online questionnaire.
|
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.
|
|
Polygamous marriage
Egyptian men aged 18 years or older who are currently married to two or more wives and complete the anonymous online questionnaire.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sexual function score measured by the Sexual Health Inventory for Men
Prazo: Baseline (single assessment at questionnaire completion)
|
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.
|
Baseline (single assessment at questionnaire completion)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with impaired sexual function
Prazo: Baseline (single assessment at questionnaire completion)
|
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.
|
Baseline (single assessment at questionnaire completion)
|
|
Sexual Quality of Life-Male questionnaire score
Prazo: Baseline (single assessment at questionnaire completion)
|
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.
|
Baseline (single assessment at questionnaire completion)
|
|
Relationship satisfaction score
Prazo: Baseline (single assessment at questionnaire completion)
|
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.
|
Baseline (single assessment at questionnaire completion)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Abul-fotouh Ahmed, MD, Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UroAzhar_11_026
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .