Smart wearable for monitoring bladder function in men with BPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study tests a lower-abdominal wearable device that uses Electrical Impedance Tomography to monitor bladder function in men with benign prostatic hyperplasia. Participants will wear the device while undergoing traditional uroflowmetry to compare measurements such as maximum and average urine flow rate and voided volume. The goal is to determine agreement between the wearable’s data and the standard test, with additional exploration of dynamic bladder volume tracking and AI-based analysis. The study is conducted at a single center and aims to assess feasibility, accuracy, and potential for at-home monitoring. Eligibility focuses on patients requiring urodynamic evaluation prior to invasive treatment, with several safety-related exclusions to reduce risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with BPH who need urodynamic tests to further evaluate the underlying pathophysiology of LUTS prior to invasive treatment.

Patients who understand and agree with the written informed consent, and voluntary to participate in the study.

Exclusion Criteria:

Patients with catheter-dependent urinary retention. Patients who cannot void \> 150ml. Patients with uncontrolled acute urinary tract infections. Patients who suffer from severe mental illness or other diseases that may affect judgment or cooperation during the study.

Patients with implanted cardiac pacemaker or other electronic implants that may potentially be interfered by the EIT device.

Patients with other conditions who are deemed unsuitable for participation by the investigator.

Where it's running

• Peking University Third Hospital
  Beijing, HaiDian, China Recruiting
• Peking University Third Hospital
  Beijing, China Not yet recruiting

Study contacts

• Principal investigator: Liu Zhuo — Peking University Third Hospital
• Study coordinator: Lin Xiushi
• Email: 2511110553@bjmu.edu.cn
• Phone: +086 15600338549

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.