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

NCT07357012 | Not Yet Recruiting

• 1 other identifier: M20251231
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Agreement of Voiding Parameters Between EIT Device and Uroflowmetry

  From device placement until completion of the voiding test, assessed on the day of the single study visit.

Study Arms (1)

Benign Prostatic Hyperplasia (BPH) Patients

Diagnostic Test: Electrical Impedance Tomography (EIT) Wearable Monitoring Device

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.

Benign Prostatic Hyperplasia (BPH) Patients

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male patients diagnosed with BPH who are scheduled for urodynamic evaluation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Liu Zhuo

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Xiushi

CONTACT

+086 15600338549; 2511110553@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)