NCT07607652

Completed

Development of a Cardiac Signal Analysis Algorithm for Bladd...

University Hospital, Lille Source

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Other study identifiers

Sponsor study identifier

2022_0653

Secondary identifiers

2022-A02836-37

OTHER · ID-RCB number, ANSM

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

June 14, 2023

Actual (reported)

Primary Completion

May 15, 2024

Actual (reported)

Study Completion

May 15, 2024

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: May 15, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 14, 2023
Actual (reported)
Primary Completion
May 15, 2024
Actual (reported)
Study Completion
May 15, 2024
Actual (reported)
First Submitted
May 19, 2026
Actual (reported)
First Posted
May 26, 2026
Actual (reported)

Last Updated: May 26, 2026
Status Verified: May 2026
Last Update Submitted: May 19, 2026

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

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

University Hospital, Lille
Otherlead

Study Sites (1)

chu de Lille

Lille, France

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

30 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Clinical Trial of New Single-use Compact Intermittent Catheter

Not ApplicableCompleted

NCT04074044

Evaluation of a New Bladder Health Mobile Application in Pregnancy

Not ApplicableCompleted

NCT05305846

Data Collection for Development of a Bladder Sensor During Urodynamics

Not ApplicableUnknown

NCT05957263

Biofeedback and Osteopathic Procedures for Daytime Urinary Incontinence

Not ApplicableUnknown

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 ®)

Contact the study team to confirm eligibility.

Primary Completion

May 15, 2024

Actual (reported)

Study Completion

May 15, 2024

Actual (reported)

Last Updated

May 26, 2026

Record last verified: 2026-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07607652
Data provider: ClinicalTrials.gov
Source updated: 2026-05-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:43 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations