Wearable bladder devices for pelvic health physical therapy clinics

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

This project tests whether a wearable bladder ultrasound and a vaginal exerciser can provide useful, real-world data for adults with bladder problems after childbirth or prostate surgery who are receiving pelvic health physical therapy.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07451106 on ClinicalTrials.gov

What this trial studies

This observational study enrolls adults referred for pelvic health physical therapy—postpartum women (≥8 weeks postpartum, adequate pelvic floor strength) and men after radical prostatectomy—and provides a wearable bladder ultrasound (DFree) and, for women, an intravaginal exerciser (Perifit). Participants use the devices between clinic visits while researchers collect device data alongside routine clinical outcome measures to compare remote signals with in‑clinic assessments. The protocol emphasizes real‑world usability, data validity, and correlation with established clinical measures. The eventual aim is a toolkit that delivers actionable data to patients and clinicians to support remote monitoring and personalized therapy.

Who should consider this trial

Good fit: Ideal candidates are adults referred for pelvic health physical therapy—postpartum women at least 8 weeks after delivery with sufficient pelvic floor strength, and men after radical prostatectomy who can use a smartphone and the devices.

Not a fit: Patients with severe cognitive, visual, or dexterity impairments; postpartum women with unhealed childbirth tears, active vaginal infection, unresolved uterine bleeding, current pregnancy, or recent pelvic PT within 3 months; and men with additional prostate surgeries, delayed catheter placement, or post‑op infection are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, these wearables could give patients and clinicians objective, real‑time bladder information to personalize pelvic floor therapy, improve symptoms, and reduce unnecessary clinic visits.

How similar studies have performed: Preliminary studies in women with multiple sclerosis have shown strong correlations with gold‑standard clinical measures, but applying bladder wearables in routine pelvic health physical therapy remains relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

San Francisco, California

• University of California San Francisco Weill Institute for Neurosciences — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Valerie Block, PT, DPTSc — University of California, San Francisco
• Study coordinator: Valerie J Block, PT, DPTSc

Conditions Postpartum Bladder Dysfunction; Post-prostatectomy Bladder Dysfunction; Bladder Dysfunction; bladder dysfunction; pelvic health physical therapy; wearables