Asuntos de TI: El Registro de Restauración Eréctil
The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
IT MATTERS is a prospective, multicenter, observational registry that is part of planned, active post market clinical follow-up (PMCF) activity associated with each device.
The study will include adult males who undergo penile prothesis implantation with a market approved BSC device to treat erectile dysfunction.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Dhahran, Arabia Saudita, 34465
- Johns Hopkins Aramco Healthcare
-
-
-
-
California
-
Los Angeles, California, Estados Unidos, 90095
- Ronald Reagan UCLA Medical Center
-
Los Angeles, California, Estados Unidos, 90033
- USC Medical Center
-
Los Angeles, California, Estados Unidos, 99048
- Tower Urology-Research Facility
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- University of Miami Hospital
-
Tampa, Florida, Estados Unidos, 33606
- USF Health South Tampa Center for Advanced Healthcare
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
-
Springfield, Illinois, Estados Unidos, 62702
- SIU School of Medicine
-
-
Indiana
-
Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Medical Center
-
-
Louisiana
-
Bossier City, Louisiana, Estados Unidos, 71111
- Willis-Knighton Medical Center
-
-
Missouri
-
St Louis, Missouri, Estados Unidos, 63110
- Washington University in St. Louis
-
-
North Carolina
-
Raleigh, North Carolina, Estados Unidos, 27609
- Duke University Medical Center
-
Salisbury, North Carolina, Estados Unidos, 28144
- W.G. Hefner VA Medical Center
-
Winston-Salem, North Carolina, Estados Unidos, 27103
- Wake Forest University
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
-
Columbus, Ohio, Estados Unidos, 43212
- Ohio State University Wexner Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University Hospital
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
-
Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84132
- University of Utah
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
-
-
-
-
-
Beijing, Porcelana, 100034
- Peking University First Hospital
-
Shanghai, Porcelana, 200080
- Shanghai General Hospital
-
Shanghai, Porcelana, 200127
- Shanghai Jiaotong University School of Medicine Renji Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult males who meet the indications for surgical correction of erectile dysfunction will be enrolled.
Descripción
Inclusion Criteria:
- ≥ 18 years of age.
- Males who are determined to be suitable candidates and scheduled to undergo surgical implantation of a market approved BSC penile prothesis by their physician.
- Willing and able to complete the informed consent process.
- Willing and able to comply with the follow-up requirements.
Exclusion Criteria:
- Males who are deemed by their physician as not suitable candidates for a penile prosthesis.
- In the opinion of the investigator, it is not in best interest of the patient or the study for the patient to participate.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
BSC Penile Prothesis Recipients
Men for whom BSC Penile Prothesis is recommended. |
The Tactra™ Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are suitable candidates for implantation procedure. The Spectra Penile Prothesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in men who are determined to be suitable candidates for implantation surgery. The AMS Ambicor inflatable penile prothesis intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence) in adult men who are determined to be suitable candidates for implantation surgery. The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). The AMS 700 Inflatable Penile Prosthesis is intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline to six months in the Erectile Function domain ofthe International Index of Erectile Function (IIEF-EF) questionnaire for Tactra
Periodo de tiempo: Baseline to 6 months
|
The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains. The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30). |
Baseline to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in depressive symptoms and overall sexual function at Post-Surgery, 6 months, and 12 months post device implantation compared to baseline, as measured by the PHQ-9 Depression Questionnaire and the IIEF: Total Score.
Periodo de tiempo: Post-Surgery, 6 months, and 12 months
|
The Patient Health Questionnaire (PHQ) is a diagnostic tool for mental health disorders used by health care professionals. The PHQ contains: mood anxiety, alcohol, eating, and somatoform modules. The PHQ-9, is a validated tool specific to depression, scoring each of the 9 DSM-IV criteria. Scored from 0-27, the PHQ-9 is separated into five different diagnoses: minimal depression (0-4), mild depression (5-9), moderate depression (10-14), moderately severe depression (15-19), and severe depression (20-27). |
Post-Surgery, 6 months, and 12 months
|
|
Change in quality of life at 6 months, and 12 months post device implantation compared to baseline as measured by the WPAI:GH Questionnaire.
Periodo de tiempo: 6 months, and 12 months
|
The WPAI:GH (Work Productivity and Activity Impairment Questionnaire: General Health) is a validated tool that asks a series of questions about the effect of subject health problems, both physical and emotional, on their ability to work and perform regular activities. The WPAI:GH outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as following 6 questions: 1 = currently employed, 2 = hours missed due to health problems, 3 = hours missed other reasons, 4 = hours actually worked, 5 = degree health affected productivity while working, 6 = degree health affected regular activities. Scores are then multiplied by 100 to be expressed in percentages. |
6 months, and 12 months
|
|
Change in erectile function at post-surgery, and 12 months post device implantation compared to baseline, as measured by the International Index of Erectile Function Domain (IIEF).
Periodo de tiempo: Post-Surgery, and 12 months
|
The International Index of Erectile Function (IIEF) is a validated, widely used, multidimensional self-report instrument for the evaluation of erectile function. It consists of 15 items that assess sexual function in five domains: erectile function (Q1, 2, 3, 4, 5,15), orgasmic function (Q9,10), sexual desire (Q11,12), intercourse satisfaction (Q 6,7,8) and overall satisfaction (Q 13,14). A score of 0-5 is awarded to each of the 15 questions. The IIEF-15 total score is the sum of the ordinal responses to the 5 domains. The erectile function (EF) domain is the most sensitive domain of the IIEF. IIEF-EF score ranges from 1 to 30 and is derived by scoring 0 (poorest function) to 5 (best function) on each of six questions function (Q1, 2, 3, 4, 5, 15). There are five categories of erectile function based on EF domain score: severe (1-10), moderate (11-16), mild to moderate (17-21), mild (22-25) and no ED (26-30). |
Post-Surgery, and 12 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Device satisfaction at post-surgery, 6 months, and 12 months a measured by the Likert scale.
Periodo de tiempo: Post-surgery, 6 months, and 12 months
|
The Likert scale has the options of Very Satisfied, Dissatisfied, Neither Satisfied nor Dissatisfied, Satisfied and Very Satisfied. Responses will be evaluated categorically. |
Post-surgery, 6 months, and 12 months
|
|
Assess for outcomes and adverse events on AMS Tools at Post Procedure.
Periodo de tiempo: Collected only at Post-Procedure
|
AMS tools will be assess by a physician survey as part of the post-procedure case report form. |
Collected only at Post-Procedure
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohit Khera, MD, Baylor College of Medicine
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
- U0670
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .