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临床试验/NCT07451106
NCT07451106进行中(未招募)不适用

Exploring Clinical Utility of Wearables for the Bladder in Pelvic Health Physical Therapy Clinics

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年7月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
2
主要终点
Comparison between in clinic and wearable post-void-residual

研究概览

简要总结

Pelvic health physical therapy (PHPT) is an evidence-based intervention for bladder dysfunction (BD) and pelvic floor disorders (PFD) in men postprostatectomy, and postpartum women. However, there is a dearth of objective outcome measures - in particular, those that can capture changes remotely, between clinic visits. In other domains, such as physical activity, wearable digital devices have started to fill this gap. The investigators aim to evaluate if commercially available wearables for the bladder (WeB) can provide valid, objective outcomes to evaluate, monitor and treat people with BD and PFD. The WeB toolkit, comprising a wearable bladder ultrasound device and an intravaginal exerciser (women only), eventually aims to provide real-world, actionable data to both users and healthcare providers, thereby improving patient outcomes through closed-loop interventions. Preliminary studies in women with multiple sclerosis have shown strong associations with gold-standard clinical measures, suggesting that WeB tools could revolutionize care for these patients. However, the effectiveness of these tools in a wider range of patient demographics, especially postpartum women, and men, has yet to be established. The investigators seeks to extend the promising pilot findings to these additional 'special' populations seen in the PHPT clinic. The investigators hypothesize that the WeB tools will retain their accuracy and utility across these diverse groups. The investigators plan to i) validate WeB in these special populations against gold-standard clinical measures for BD, ii) evaluate the responsiveness of WeB tools to changes in outcomes before and after PHPT and iii) assess user experience in these populations. By ensuring the WeB tools' broad applicability, this research seeks to close the gap in continuous care and enable objective, personalized treatment strategies. The outcomes will have significant implications for the management of BD and PFD, potentially offering a more inclusive and empowering approach to patient care in women postpartum and men post-prostatectomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referral for pelvic health physical therapy
  • 18 years of age or older
  • Postpartum women: 8 or more weeks postpartum, manual muscle test greater than or equal to 2/5 pelvic floor muscle strength via Modified Oxford Scale
  • Men: status post radical prostatectomy after catheter removal

排除标准

  • cognitive, dexterity or visual impairment so severe that it precludes use of the neurotechnology tool or ability to use a smartphone
  • Postpartum women: any unhealed tears from childbirth, active vaginal infection or unresolved uterine bleeding, currently pregnant, have seen a pelvic health physical therapist in the past 3 months
  • Men: status post another surgery related to prostate, catheter placement more than 1 week after radical prostatectomy, post-op infection

研究组 & 干预措施

Men post-prostatectomy with bladder dysfunction

干预措施: DFree Non-Invasive Bladder Ultrasound (Other)

Men post-prostatectomy with bladder dysfunction

干预措施: Exit interview (Other)

Postpartum women with bladder dysfunction

干预措施: DFree Non-Invasive Bladder Ultrasound (Other)

Postpartum women with bladder dysfunction

干预措施: Perifit Kegel Exerciser (Other)

Postpartum women with bladder dysfunction

干预措施: Exit interview (Other)

Women with bladder dysfunction

干预措施: DFree Non-Invasive Bladder Ultrasound (Other)

Women with bladder dysfunction

干预措施: Perifit Kegel Exerciser (Other)

Women with bladder dysfunction

干预措施: Exit interview (Other)

Clinicians

Clinicians will be interviewed at the completion of the study to assess utility of wearables for the bladder in clinical care

干预措施: Exit interview (Other)

结局指标

主要结局

Comparison between in clinic and wearable post-void-residual

时间窗: baseline

Wearable ultrasound (DFree) derived post-void-residual validation in post prostatectomy and post-partum populations. Logistic regression, to evaluate associations while controlling for potential confounding factors. Intraclass correlation coefficients (ICC) and the smallest real difference (SRD) will evaluate the smallest change that can be considered meaningful.

Bladder wearables - usefulness (patient groups)

时间窗: through study completion, an average of 3 months

Qualitative (modified Health IT Usability Evaluation Model) survey evaluating bladder wearable devices in these populations - assessing patient preference, perceived usability and effectiveness (scored 1-5 on likert scale)

Bladder wearables - usefulness (clinician)

时间窗: through study completion, an average of 3 month

Clinicians will complete the Health ITUES questionnaire and asked to rate the following questions on a likert scale from 0-5: 1) how useful the devices are for helping patients reach physical therapy goals

Feasibility of deploying bladder wearables

时间窗: through study completion, an average of 3 months

will calculate the % of participants completing pelvic health physical therapy and still using the tool(s), considering the satisfaction questionnaire feedback. Generalized linear models with Gamma variance to account for potential covariates, including age, vaginal vs cesarean delivery, time postpartum. A tool with \>75% adherence will be considered for further studies; reasons for lower adherence will be explored through exit surveys and be classified according to whether barriers to adherence can be addressed or not.

次要结局

  • Post-partum vs general women - device usability(through study completion - an average of 3 months)
  • Evaluate utility of in-clinic and wearable derived post-void-residual(through study completion, an average of 3 months)
  • Usability (clinicians)(at study completion - an average of 1 year)
  • effectiveness (patient)(at study completion - an average of 3 months post baseline)
  • Evaluate differences between utility of in-clinic and wearable derived post-void-residual, between general and postpartum women(through study completion, an average of 3 months)
  • effectiveness (patient groups)(at study completion - an average of 3 months, post baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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