Development of a Cardiac Signal Analysis Algorithm for Bl... | NCT07607652

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

NCT07607652

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

May 26, 2026Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Urinary Incontinence

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-A02836-37	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2023Actual

Primary Completion Date

May 15, 2024Actual

Completion Date

May 15, 2024Actual

First Submitted Date

May 19, 2026

First Submission Date that Met QC Criteria

May 19, 2026

First Posted Date

May 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 ®)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided