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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07607652

Acronym

ENURESIA 1

Enrollment

Registered

2026-05-26

Start date

2023-06-14

Completion date

2024-05-15

Last updated

2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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 ®)

Design outcomes

Primary

Measure	Time frame	Description
low-frequency variability index	15 minutes	develop an algorithm for calculating a low-frequency variability index (LFVI) that enables an effective assessment of bladder filling.

Countries

France

Outcome results