The Nolix Feasibility Efficacy and Safety Study
9 de agosto de 2021 actualizado por: Gynamics LTD
A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls.
The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women.
In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device.
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase.
Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels.
The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Haifa, Israel
- Carmel Medical Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Females aged 22 and above.
- Suffering from Stress Urinary Incontinence.
- Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study.
Exclusion Criteria:
- Age ≤ 21 years.
- Pregnant or planning to become pregnant during the study.
- Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- Severely atrophic vagina.
- A history of Toxic Shock Syndrome (TSS).
- Active urinary tract or vaginal infection.
- Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
- Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
- Vaginal surgery within the last 3 months prior to entering the study.
- Has experienced difficulties with the use of intra-vaginal devices, including tampons.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dispositivo Nolix
Comparación del uso del dispositivo con la fase de no tratamiento (solo almohadillas)
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For temporary management of SUI
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
Periodo de tiempo: 21 days
|
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.
|
21 days
|
|
Device-related adverse events
Periodo de tiempo: 21 days
|
Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
|
21 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in number of self-reported incontinence episodes.
Periodo de tiempo: 21 days
|
Change in number of self-reported incontinence episodes per week from the control period to the Nolix device use period.
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21 days
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More than 50% reduction in the number of self-reported daily incontinence episodes.
Periodo de tiempo: 21 days
|
Percentage of subjects who experience a greater than 50% reduction in the number of self-reported daily incontinence episodes from the baseline period to the Nolix device use period.
|
21 days
|
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Changes in Quality of Life (QoL).
Periodo de tiempo: 21 days
|
The QoL Questionnaire (measured on a 0-100 scale) will be performed at baseline and after the device-use period and refer to areas which may have been influenced or changed by accidental urine loss and/or prolapse.
A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life.
In the same manner, a reduction in scores from baseline reflects improved quality of life.
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21 days
|
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Changes in Leak Score.
Periodo de tiempo: 21 days
|
Changes in Leak Score from the baseline period to the Nolix device use period, as measured using the Leak Score Questionnaire.
The Leak Score Questionnaire will be performed (on a 0-3 scale) to evaluate the subjective perception of incontinence during eight effort demanding activities: coughing, laughing, sneezing, jumping, lifting heavy objects, walking, running, and going to the gym.
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21 days
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PWG measured continuously.
Periodo de tiempo: 21 days
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PWG measured continuously (as opposed to responder analysis), using the same definition of PWG as described above, without transformation to percent.
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21 days
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Comfort during Nolix device use.
Periodo de tiempo: 21 days
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Comfort during Nolix device use will be measured through the Satisfaction Questionnaire, using a 10-point scale (where 1 is the most negative response and 10 the most positive, during the use of the device).
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21 days
|
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Overall perception of improvement.
Periodo de tiempo: 21 days
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Overall perception of improvement following the use of the Nolix device, as measured using the Patient Global Impression of Improvement (PGI-I) Scale, measured on a 7-point scale (where 1 is the most positive response and 7 the most negative response).
|
21 days
|
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Overall satisfaction: Patient Satisfaction Question (PSQ)
Periodo de tiempo: 21 days
|
Overall satisfaction with the use of the Nolix device, as measured using the Patient Satisfaction Question (PSQ),selecting one of the following answers: 'Completely'; 'Somewhat'; or 'Not at all'.
|
21 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Boris Fridman, Dr., Carmel Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2019
Finalización primaria (Actual)
31 de marzo de 2020
Finalización del estudio (Actual)
31 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2019
Primero enviado que cumplió con los criterios de control de calidad
27 de octubre de 2019
Publicado por primera vez (Actual)
29 de octubre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NLX-002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
All personal data gathered in this trial will be treated in strictest confidence by investigators, monitors, sponsor's personnel and independent ethics committee.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Nolix Device
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Gynamics LTDTerminadoIncontinencia urinaria de esfuerzoIsrael