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El ensayo clínico NCT05715268 (WeB) para Esclerosis múltiple, Vejiga Urinaria, Hiperactiva está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad de California en San FranciscoWearables for the Bladder: an In-home Treatment Feasibility Pilot Study (WeB)
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El estudio clínico NCT05715268 (WeB) es un ensayo intervencionista para Esclerosis múltiple, Vejiga Urinaria, Hiperactiva. Su estado actual es: activo, no reclutando. El ensayo se inició el 15 de marzo de 2023, con el objetivo de reclutar a 20 participantes. Dirigido por la Universidad de California en San Francisco, se espera que finalice el 25 de septiembre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 10 de marzo de 2025.
Resumen
The goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (PFPT) to bladder function, in people with multiple sclerosis (MS).
Descripción detallada
The participants baseline pelvic floor and bladder function will be assessed by a pelvic floor physical therapist as per standard care, and online MS-symptom questionnaires (i.e., quality of life, bladder bother/symptoms, falls, fatigue, depression). Participants will be trained on the maintenance and use of "wearable for the bladder" (WeB) devices. Participants will receive standard PFPT intervention care, and will be asked to further train using the WeB devices. 8-10 sessions will be conducted over telehealth or in person as per standard protocol. At 12 weeks, participants will return to clinic for pelvic floor and bladder function assessment.
A control group will receive standard PFPT intervention care as well as online MS-symptom questionnaires.
Título oficial
Moving MS Bladder Dysfunction Into the 21st Century: Developing Novel and Accessible Ways to Treat Dysfunction in the Home - a Three Month Single Arm Open Label Feasibility Pilot With Waitlist Control
Condiciones médicas
Esclerosis múltipleVejiga Urinaria, HiperactivaOtros ID del ensayo
- WeB
- A137172
Número del NCT
Inicio del ensayo (real)
2023-03-15
Última actualización
2025-03-10
Fecha de finalización (estimada)
2025-09-25
Inscripción (prevista)
20
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
multiple sclerosis
remote
wearables
overactive bladder
pelvic floor physical therapy
remote
wearables
overactive bladder
pelvic floor physical therapy
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalWeB and pelvic floor physical therapy group This group will receive standard PFPT as well as WeB device for 12 weeks, and MS-symptom (including bladder bother) related questionnaires at baseline, 12 weeks and 6 months post intervention. Participants will also be provided with a remote activity monitor to use during the study. | Web Participants will be given WeB devices and trained on the use of these devices for home therapy, including the associated mobile applications. Participants will be given home programs and given a schedule to use the WeB devices at home on their own time. At their standard visit participants will have their WeB device use checked and progressed as the therapist deems appropriate.
An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion. Standard Pelvic Floor Physical Therapy Baseline will consist of a standard PFPT evaluation. Regular visits (tele-video visits or in-person depending on the patients preference) will be scheduled every week for the first 4 weeks and then every other week at the discretion of the therapist. A total of 8-10 visits will be scheduled over the 12 weeks of the study. Participants will be given home exercise programs (as per standard PFPT).
An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion. |
Comparador activoControl pelvic floor physical therapy group This group will receive standard PFPT for 12 weeks. MS-symptom (including bladder bother) related questionnaires at baseline, 12 weeks and 6 months after the last PFPT visit.
Patients will be invited to use WeB devices after this time. | Standard Pelvic Floor Physical Therapy Baseline will consist of a standard PFPT evaluation. Regular visits (tele-video visits or in-person depending on the patients preference) will be scheduled every week for the first 4 weeks and then every other week at the discretion of the therapist. A total of 8-10 visits will be scheduled over the 12 weeks of the study. Participants will be given home exercise programs (as per standard PFPT).
An in-person visit will be scheduled to re-evaluated participants at the 12 week study completion. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Net Promoter Score | This is a response to a single question: "How likely would you be to recommend \[participation in a study or treatment like this\] to a friend or family member with Multiple Sclerosis?" Net promoter scores range from 0 (would not recommend) to 10 (would definitely recommend). | 12 weeks |
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use | In response to four statements about the ease of use for the wearables for the bladder (WeB): ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less ease of use. | 12 weeks |
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness | In response to nine statements about the Perceived usefulness of the wearables for the bladder (WeB) ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 5-20. Lower scores relate to less perceived usefulness. | 12 weeks |
System usability scale | It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree (5) to Strongly disagree (1) - ranking each from 1 (strongly disagree) to 5 (strongly agree). Scores range from 10-100. Lower scores relate to less usability. | 12 weeks |
Adherence as measured by percent usage | Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration. | 12 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in Overactive bladder symptom scale; OABSS | The questionnaire consists of 4 questions on overactive bladder symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and urge urinary incontinence (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. | Baseline and 12 weeks |
Change in Overactive bladder symptom scale; OABSS | The questionnaire consists of 4 questions on overactive bladder symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and urge urinary incontinence (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity. | Baseline and 9 months |
Change in the number of daily leakage episodes | Change in number of leaks per day as measured by the wearables for the bladder application. The patient will manually enter the number of leaks into the application. | Baseline and 12 weeks |
Change in the number of daily leakage episodes | Change in number of leaks per day as measured by the wearables for the bladder application. The patient will manually enter the number of leaks into the application. | Baseline and 9 months |
Change in the frequency of daily voiding episodes | Change in the frequency of voids per day as measured by the wearables for the bladder application. The patient will manually enter voids into the application. | Baseline and 12 weeks |
Change in the frequency of daily voiding episodes | Change in the frequency of voids per day as measured by the wearables for the bladder application. The patient will manually enter voids into the application. | Baseline and 9 months |
Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29) | Measurement of changes in quality of life via the MSQOL-29: consists of seven multi-item subscales: 'physical function' (six items); 'sexual function' (four items); 'bodily pain', 'emotional well-being', 'energy', 'cognitive function' and 'health distress' (three items); and four single-item subscales ('social function', 'health perceptions', 'overall quality of life', and 'change in health') which form two composite scores (Physical Health Composite, (PHC) and Mental Health Composite, (MHC)) | Baseline and 12 weeks |
Change in the SymptoMScreen survey | Measurement of changes in quality of life via the SymptoMScreen - a 12 question survey asking about MS symptoms affecting everyday life. Each question is graded on a scale of 0 - not affected at all, to 6 - Total limitation. Scores are summed and range from 0 -72. | Baseline and 9 months |
Satisfaction with using WeB devices | Using a single question ("Do you like this tool?") graded on a Likert scale (0, do not like at all, 100, like very much). Higher scores indicate higher satisfaction. | 12 weeks |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
- MS diagnosis
- Assigned Female at birth and whose sex is currently Female
- Mild/moderate bladder dysfunction (bowel/bladder functional systems scores = 0-2 or Bladder control scale >0)
- California residents
- Wifi in the home and personal smartphone (using Apple operating system)
- Able to walk with or without assistive device
- Manual muscle test score of 2 or more.
- Undergone treatment for bladder dysfunction symptoms within 3 months
- Current urinary tract infection
- Recent (~30 days) relapse
- Any cognitive, dexterity or visual impairment so severe that it precludes use of the wearables for the bladder tool or ability to use a smartphone
- Pregnancy
Universidad de California en San Francisco704 ensayos clínicos activos para explorarNational Multiple Sclerosis SocietyNo hay datos de contacto.
1 Sitios del ensayo en 1 países
California
University of California San Francisco, Weill Institute for Neurosciences, San Francisco, California, 94158, United States