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- Ensayo clínico NCT03783741
The Biopsychosocial Burden of Prostate Biopsy
The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A prospective, longitudinal and observational study in which the sexually active patients were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357).
Consecutive patients who were attended by urologist and present prostate cancer suspicions (PSA> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at three different moments of the biopsy:
- Seven days before the biopsy procedure (T0);
- 20 days after the biopsy, upon receiving the histopathological result, before becoming aware of it (T1);
- 40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one consecutive patients were invited to participate in the study, 10 of them had no active sexual life and 9 answered the questionnaires only at the first moment, were excluded; 47 responded at three times (T0, T1, and T2).
Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); - Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional thermometers.
The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of variance) for repeated measures with the variables transformed in stations. The comparison between patients and variables was performed using the Mann-Whitney test. The sample power was calculated and the level of significance considered was 5%.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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Campinas, SP, Brasil, 13083-887
- Hospital das Clínicas Unicamp
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- prostate cancer suspicion (PSA > 4 ng / dL, digital rectal examination)
Exclusion Criteria:
- not agree to participate
Plan de estudios
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Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Erectile Function
Periodo de tiempo: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Voiding Function
Periodo de tiempo: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Beck scale
Periodo de tiempo: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Beck Anxiety Index - BAI (0-63; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Emotional thermometers
Periodo de tiempo: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Thermometer score (range 0-10; higher worse)
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Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Naccarato AM, Reis LO, Matheus WE, Ferreira U, Denardi F. Barriers to prostate cancer screening: psychological aspects and descriptive variables---is there a correlation? Aging Male. 2011 Mar;14(1):66-71. doi: 10.3109/13685538.2010.522277. Epub 2010 Oct 12.
- Laranja WW, Sanches BCF, Voris BRI, Alonso JCC, Simoes FA, Rejowski RF, Reis LO. The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report. Prostate Cancer. 2019 Apr 1;2019:2653708. doi: 10.1155/2019/2653708. eCollection 2019.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Prostate Biopsy Burden
Plan de datos de participantes individuales (IPD)
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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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