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Recruiting
NCT07357012
A Smart Wearable Device for Monitoring Urination Function in Benign Prostatic Hyperplasia
Conditions: Benign Prostatic Hyperplasia
Sex: Male
Healthy volunteers: No
Enrollment: 40
Sponsor: Peking University Third Hospital
Location: Peking University Third Hospital Beijing HaiDian
Summary
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 could lead to a new tool for doctors to better monitor patients with BPH, even potentially at home.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07357012). StuddyBuddy aggregates publicly available trial information.