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

Sponsor
Peking University Third Hospital
Study ID
NCT07357012
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electrical Impedance Tomography (EIT) Wearable Monitoring Device — DIAGNOSTIC_TEST
    A non-invasive, portable device that uses an array of surface electrodes placed on the lower abdomen to measure bioimpedance changes. It reconstructs real-time, three-dimensional images and volume data of the bladder during filling and voiding phases.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Benign Prostatic Hyperplasia (BPH) Patients

Primary Outcome Measure

Agreement of Voiding Parameters Between EIT Device and Uroflowmetry [ Time Frame: From device placement until completion of the voiding test, assessed on the day of the single study visit. ]

Central Contacts

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