Urinary IncontinenceENURESIA 1NCT07607652
Development of a Cardiac Signal Analysis Algorithm for Bladder Filling Assessment: Pilot Study
An observational study of Urinary Incontinence, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility
Who may be able to join
- patient undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility
Who cannot join
- 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
Show all 9Show fewer
- Neurological condition / dysfunction
- Subjects with an implanted medical device (pacemaker, etc.)
- Allergy to a component of the PC-ECG 1200 device (Norav medical ®)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
low-frequency variability index
develop an algorithm for calculating a low-frequency variability index (LFVI) that enables an effective assessment of bladder filling.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start14 Jun 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607652
- Sponsor's protocol ID
- 2022_0653
- Other IDs
- 2022-A02836-37
- Acronym
- ENURESIA 1
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Cardiac Signal Analysis Algorithm for Bladder Filling Assessment: Pilot Study
- ClinicalTrials.gov ID
- NCT07607652
- Acronym / sponsor ID
- ENURESIA 1 / 2022_0653
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility
Key inclusion criteria (1 listed)
- patient undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility
Key exclusion criteria (9 listed)
- Urge urinary incontinence or mixed urinary incontinence
- Bladder emptying disorder
- Bladder sensory disorder
- History of pelvic surgery
- History of perineal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
low-frequency variability index
Time frame: 15 minutes
develop an algorithm for calculating a low-frequency variability index (LFVI) that enables an effective assessment of bladder filling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low-frequency variability index (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.