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

NCT07607652 | Completed

• 2 other identifiers: 2022_06532022-A02836-37
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• low-frequency variability index

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

  15 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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 ®)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

chu de Lille

Lille, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 14, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

FR (1)