Development of a Cardiac Signal Analysis Algorithm for Bladder Filling Assessment: Pilot Study (ENURESIA 1)

University Hospital, Lille

Status: Completed

Conditions: Urinary Incontinence

Study type: Observational

Funder types: Other

Identifiers

NCT07607652

2022-A02836-37 (Other Identifier)

2022_0653

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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 ®)