- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01601262
Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment
Efficacy and Safety of a Second Series of Low Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The patients will be selected out of the patients with Erectile Dysfunction who received Low intensity shock waves and Were Partial Responders to the treatment.
At the first meeting the patient will receive a full explanation of the study, the potential efficacy and risks. After that the patient will be asked to sign an informed consent form. The patient's general medical condition and any problems related to sexual dysfunction are already known from the previous study he was participating. Also the patient's sexual function is already known by sexual function questionnaires that were filled out in previous study. The criteria for inclusion and exclusion will be reviewed, as well as physical examination. Then shall the patient obtain reporting sexual encounter diaries (SEP) and will be asked to avoid using PDE5i's for a month (washout), if he did not do so of some reason after ending the previous study, then it would be the first visit (Visit 1). At visit 1 The patient will be questioning the sexual function questionnaires without PDE5i's and will pass examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an invasive test (not involved in inserting an instrument or any medication) and is painless. The patient may be asked to also undergo Doppler ultrasound. At the end of visit 1 the patient will begin Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments). Four weeks after the treatment series ends the patient will come for another visit and will be asked to fill in questionnaires and perform the FMD and/or Doppler ultrasound test again. The patient's ED condition will be followed up for a long term after the end of his participation in the study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ilan Gruenwald, MD
- Número de teléfono: 00972-4-8542882
- Correo electrónico: i_gruenwald@rambam.health.gov.il
Copia de seguridad de contactos de estudio
- Nombre: Yoram Vardi Vardi, Prof. MD
- Número de teléfono: 00972-4-8542819
- Correo electrónico: yvardi@rambam.health.gov.il
Ubicaciones de estudio
-
-
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Haifa, Israel
- Rambam Health Care Campus
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Contacto:
- Ilan Gruenwald, MD
- Número de teléfono: 00972-4-8542882
- Correo electrónico: i_gruenwald@rambam.health.gov.il
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Investigador principal:
- Ilan Gruenwald, MD
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Sub-Investigador:
- Boaz Appel, MD
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Sub-Investigador:
- Yaron Ofer, MD
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Sub-Investigador:
- Suliman Nassar, MD
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Sub-Investigador:
- Omar Massarwa, RN BA
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Sub-Investigador:
- Ezra Gerber, RN BA
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Contacto:
- Yoram Vardi, Prof. MD
- Número de teléfono: 00972-4-8542819
- Correo electrónico: yvardi@rambam.health.gov.il
-
Sub-Investigador:
- Yoram Vardi, Prof.MD
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Sub-Investigador:
- Arik Shechter, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Incomplete response to active treatment (not placebo) on first round but patient is still unsatisfied.
- Recurring ED (had improved on first round of shock wave therapy but after a certain period of time became clinically worse again) after shock wave therapy.
- A minimum of two sexual attempts per month.
- An IIEF-ED domain score ≤ 25 post screening, with or without PDE5i intake according to assessment on final visit of Shockwave previous treatment.
- A stable heterosexual relationship with the same partner for more than three months
Exclusion Criteria:
- Subjects that did not respond at all to the first round as well as those that did not respond sufficiently.
- Any pelvic surgery during the period after the first round.
- Any unstable medical or psychiatric condition, spinal cord injury, or penile anatomical abnormalities arising during this period .
- cardiovascular conditions that prevent sexual activity.
- Recent Use of anti-androgens, or oral or injectable androgens
- Recent hormonal, neurologic, or psychological pathology
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Abierto
|
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks.
Full description of treatment series can be seen in the detailed protocol.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
IIEF-ED Domain score
Periodo de tiempo: 3 months
|
Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Rigidity Score Questionaire
Periodo de tiempo: 3 months
|
An increase of at least 1 point is considered as a treatment success.
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ilan Gruenwald, MD, Rambam Health Care Campus
- Director de estudio: Yoram Vardi, Prof. MD, Rambam Health Care Campus
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 0179-12-RMB
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. .
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