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A Smart Wearable Device for Monitoring Urination Function in Benign Prostatic Hyperplasia

Recruitingn/aAges any - anyMalePeking University Third Hospital
NCT07357012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Benign Prostatic Hyperplasia (BPH) is a common condition that can cause bothersome urination problems and reduce quality of life. Accurately measuring how the bladder empties is important for diagnosis and treatment, but current methods like uroflowmetry can be inconvenient and are done only at a clinic. This study aims to test a new, non-invasive smart wearable device that uses Electrical Impedance Tomography (EIT) to monitor bladder function in patients with BPH. The device is worn on the lower abdomen. In this study, participants will use this EIT device while also undergoing the standard uroflowmetry test. The main goal is to see how well the measurements from the new device (like urine flow rate and volume) agree with those from the standard test. The study hopes to show that this wearable device can accurately and comfortably track bladder function over time. If successful, it co

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📋 Eligibility rules (as published)
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.
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What it tests

  • Electrical Impedance Tomography (EIT) Wearable Monitoring Device
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Where

2 sites
Peking University Third Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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