Skip to main content
OpenTrials
Completed

NCT Number: NCT07607652

Development of a Cardiac Signal Analysis Algorithm for Bladder Filling Assessment: Pilot Study

The puropose of this clinical trial is to build a database of signals issued from the device to delvelop signal processing algorithms to calculat the LFVI.

This study will be carried out in the urology department of the Claude Huriez Hospital.

Electrods will be placed on the patient body to capture the ECG during the urodynmic evaluation.

The recording of the ECG will last fir the duration of the evaluation. This procedure will not affect the usual care of the patient

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

chu de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility

Exclusion criteria

  • Urge urinary incontinence or mixed urinary incontinence
  • Bladder emptying disorder
  • Bladder sensory disorder
  • History of pelvic surgery
  • History of perineal surgery
  • History of spinal surgery
  • Neurological condition / dysfunction
  • Subjects with an implanted medical device (pacemaker, etc.)
  • Allergy to a component of the PC-ECG 1200 device (Norav medical ®)

Treatment and study plan

Primary outcomes

  1. low-frequency variability index

    Time frame: 15 minutes

    develop an algorithm for calculating a low-frequency variability index (LFVI) that enables an effective assessment of bladder filling.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: ENURESIA 1

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.