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L'essai clinique NCT05715268 (WeB) pour Sclérose en plaques, Vessie hyperactive est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Wearables for the Bladder: an In-home Treatment Feasibility Pilot Study (WeB)

Actif, pas en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'étude clinique NCT05715268 (WeB) est un essai interventionnel pour Sclérose en plaques, Vessie hyperactive. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 15 mars 2023 et vise à recruter 20 participants. Dirigé par l'Université de Californie à San Francisco, l'essai devrait être terminé d'ici le 25 septembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 10 mars 2025.
Résumé succinct
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).
Description détaillée
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.

Titre officiel

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

Conditions
Sclérose en plaquesVessie hyperactive
Autres identifiants de l'essai
  • WeB
  • A137172
Numéro NCT
NCT05715268
Date de début (réel)
2023-03-15
Dernière mise à jour publiée
2025-03-10
Date de fin (estimée)
2025-09-25
Inscription (estimée)
20
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Mots clés
multiple sclerosis
remote
wearables
overactive bladder
pelvic floor physical therapy
Objectif principal
Traitement
Plan d'attribution
Non aléatoire
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalWeB 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.
Comparateur actifControl 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.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
  • 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
University of California, San Francisco logoUniversité de Californie à San Francisco
National Multiple Sclerosis Society logoNational Multiple Sclerosis Society
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays

California

University of California San Francisco, Weill Institute for Neurosciences, San Francisco, California, 94158, United States