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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence as measured by percent usage
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
WeB 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.
干预措施: WeB (Device)
WeB 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.
干预措施: Standard pelvic floor physical therapy (Other)
Control 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.
干预措施: Standard pelvic floor physical therapy (Other)
结局指标
主要结局
Adherence as measured by percent usage
时间窗: 12 weeks
Usage ranges from 0-100% use, where 100% use would be total adherence to prescribed use duration.
Net Promoter Score
时间窗: 12 weeks
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).
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Ease of use
时间窗: 12 weeks
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.
Health Information Technology Usability Evaluation Scale (Health-ITUES) - Perceived usefulness
时间窗: 12 weeks
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.
System usability scale
时间窗: 12 weeks
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.
次要结局
- Change in the number of daily leakage episodes(Baseline and 9 months)
- Change in Overactive bladder symptom scale; OABSS(Baseline and 9 months)
- Change in the frequency of daily voiding episodes(Baseline and 9 months)
- Change in the SymptoMScreen survey(Baseline and 9 months)
- Satisfaction with using WeB devices(12 weeks)
- Change in the 29 item- multiple sclerosis quality of life survey (MSQOL-29)(Baseline and 12 weeks)
- Change in Overactive bladder symptom scale; OABSS(Baseline and 12 weeks)
- Change in the number of daily leakage episodes(Baseline and 12 weeks)
- Change in the frequency of daily voiding episodes(Baseline and 12 weeks)