Urinary IncontinenceAP-SUNCT04008108
Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
A study testing Activity sensor in people with Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Activity sensor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jul 2019to 24 Oct 2023
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Surgical indication of urinary incontinence treatment with artificial urinary sphincter implantation
- Patient informed and not opposed to the research
- Reading and speaking comprehension of the French language
Who cannot join
- Patient under guardianship or curators
- Contraindication to the placement of an artificial urinary sphincter
- Patients requiring walking assistance (canes, walker, wheelchair)
- Revisions of artificial urinary sphincter already implanted
- Cognitive impairment deemed incompatible with research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Read more
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
Read the detailed description
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
The artificial urinary sphincter (AUS) implantation is an effective treatment on stress urinary incontinence in men and women. Currently the PadTest/24 hours is the reference for his evaluation.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
The research is a monocentric, prospective study.
The Primary objective of this study is to evaluate the variation of physical activity measured by the number of steps per day, before AUS implantation and 3 months after the activation of the sphincter.
For that, the primary outcome measure is the number of steps per day measured 24h/24 for 7 consecutive days by activity sensor, before AUS implantation and 3 months after activation of the sphincter.
All adult patients (men and women) with a surgical indication for urinary incontinence treatment by AUS in the urology department of Pitié-Salpêtrière hospital will be screened for eligibility.
Four visits will be programed as standard of care :
- During the first visit, patients will be informed of the study and their agreement will be recorded. Patients' eligibility will be checked.
- AUS implantation
- AUS activation
- AUS follow-up, around fourteen weeks after activation The activity sensor, the Pad/Test/24 hours and questionnaires such as eQOL will be performed at home before AUS implantation, 1 month after the AUS activation and 3 months after the AUS activation.
- Conditions
- Urinary Incontinence
- Being tested
- Activity sensor
- Keywords
- urinary incontinence, artificial urinary sphincter, physical activity, number of steps per day, activity tracker
- Medical subject headings
- Urinary Incontinence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity sensorOther
Activity sensor worn on the wrist during 7 days, 24h/24 to evaluate physical activity of patient (measured by the number of step per day) before and after Artificial Urinary Sphincter Implantation.
| Study group | Role | What they receive |
|---|---|---|
| Patient with urinary incontinence | Experimental | Patient with urinary incontinence Receives: Other: Activity sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps per day, during 7 days at 3 months of the AUS activation
Number of steps per day measured 24h/24 for 7 consecutive days by the activity sensor, at 3 months after activation of the AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
Secondary outcomes (6)
Number of steps per day, during 7 days, at 1 month of the AUS activation
Number of steps per day measured 24h/24 for 7 consecutive days by the activity sensor, at 1 month after activation of the AUS.
1 month after activation of the AUS is corresponding to 24 weeks from the inclusion (6 months).
Measured: Through the study completion, an average of 6 months
Other activity sensor data (heart rate)
Heart rate measured by the activity sensor preoperatively and at 1 month and 3 months after activation of the AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
Other activity sensor data (sedentary and activity percentage in the day)
Sedentary and activity percentage a day measured by the activity sensor preoperatively and at 1 month and 3 months after activation of the AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
Incontinence Quality of Life (I-QOL)
I-QOL is a self-report Quality of Life measure specific to urinary problems. The I-QOL is commonly used and consists of 22 items, all of which use a five-point ordinal response scale in which 1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, and 5 = not at all.
I-QOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.
Scale score = ((The sum of the items - lowest possible score) / Possible raw score range ) x 100.
Questionnaire I-QoL fulfilled before implantation and 3 months after activation of AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
International Physical Activity Questionnaire (IPAQ)
IPAQ is a 8 items questionnaire that assess 3 types of activity (walking, moderate-intensity activities and vigorous-intensity activities) in the following domains: leisure time, domestic/gardening, work-related, transport-related. It provide separate scores on each type of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each type of activity. A Metabolic Equivalent Task (MET) is a multiple of the estimated resting energy expenditure.
Walking MET-minutes/week=3.3*walking minutes*walking days Moderate MET-minutes/week=4.0*moderate-intensity activity minutes*moderate days Vigorous MET-minutes/week=8.0*vigorous-intensity activity minutes*vigorous-intensity days Total =sum of Walking+Moderate+Vigorous METminutes/week scores.
Questionnaire IPAQ fulfilled before implantation and 3 months after activation of AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
PAD-test / 24h
PAD-test / 24h performed at home preoperatively and 3 months after activation of AUS.
3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
Measured: Through the study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start29 Jul 2019
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre MOZER, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008108
- Sponsor's protocol ID
- APHP190234
- Other IDs
- 2019-A00680-57
- Acronym
- AP-SU
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2019
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
- ClinicalTrials.gov ID
- NCT04008108
- Acronym / sponsor ID
- AP-SU / APHP190234
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, artificial urinary sphincter, physical activity, number of steps per day, activity tracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 5 Jul 2019 (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 management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
Detailed description
The management of urinary incontinence seems to improve daily activities and the practice of physical activity, according to the literature. Unfortunately, all of these studies are based on self-questionnaires with the disadvantages of self-evaluation, more subjective.
The artificial urinary sphincter (AUS) implantation is an effective treatment on stress urinary incontinence in men and women. Currently the PadTest/24 hours is the reference for his evaluation.
For several years activity sensors have been used in the medical field (rheumatology, cardiology, diabetology, etc.). They allowed the evaluation of physical activity in real life situations, whether to evaluate the degree of severity of a pathology or the impact of a new treatment on the resumption of activities.
Activity sensors are devices that transform body motion into digital measurements. They provide detailed information on the frequency, duration, intensity and type of movement to determine, for example, the number of steps taken, the distance traveled, calories burned and the quality of sleep.
It is hypothesized that urinary incontinence treatment can increase physical activity and so improve the quality of life of patients, that can be measure by activity sensors.
The research is a monocentric, prospective study.
The Primary objective of this study is to evaluate the variation of physical activity measured by the number of steps per day, before AUS implantation and 3 months after the activation of the sphincter.
For that, the primary outcome measure is the number of steps per day measured 24h/24 for 7 consecutive days by activity sensor, before AUS implantation and 3 months after activation of the sphincter.
All adult patients (men and women) with a surgical indication for urinary incontinence treatment by AUS in the urology department of Pitié-Salpêtrière hospital will be screened for eligibility.
Four visits will be programed as standard of care :
- During the first visit, patients will be informed of the study and their agreement will be recorded. Patients' eligibility will be checked.
- AUS implantation
- AUS activation
- AUS follow-up, around fourteen weeks after activation The activity sensor, the Pad/Test/24 hours and questionnaires such as eQOL will be performed at home before AUS implantation, 1 month after the AUS activation and 3 months after the AUS activation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with urinary incontinence | Experimental | Other: Activity sensorPatient with urinary incontinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Surgical indication of urinary incontinence treatment with artificial urinary sphincter implantation
- Patient informed and not opposed to the research
- Reading and speaking comprehension of the French language
Key exclusion criteria (5 listed)
- Patient under guardianship or curators
- Contraindication to the placement of an artificial urinary sphincter
- Patients requiring walking assistance (canes, walker, wheelchair)
- Revisions of artificial urinary sphincter already implanted
- Cognitive impairment deemed incompatible with research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity sensorActivity sensor worn on the wrist during 7 days, 24h/24 to evaluate physical activity of patient (measured by the number of step per day) before and after Artificial Urinary Sphincter Implantation. | Other | Patient with urinary incontinence |
Primary outcome
Number of steps per day, during 7 days at 3 months of the AUS activation
Time frame: Through the study completion, an average of 8 months
Number of steps per day measured 24h/24 for 7 consecutive days by the activity sensor, at 3 months after activation of the AUS. 3 months after activation of the AUS is corresponding to 32 weeks from the inclusion (8 months).
6 secondary outcomes
Number of steps per day, during 7 days, at 1 month of the AUS activation
Time frame: Through the study completion, an average of 6 months
Other activity sensor data (heart rate)
Time frame: Through the study completion, an average of 8 months
Other activity sensor data (sedentary and activity percentage in the day)
Time frame: Through the study completion, an average of 8 months
Incontinence Quality of Life (I-QOL)
Time frame: Through the study completion, an average of 8 months
International Physical Activity Questionnaire (IPAQ)
Time frame: Through the study completion, an average of 8 months
PAD-test / 24h
Time frame: Through the study completion, an average of 8 months
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 2 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
Pierre MOZER, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity sensor in people with Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 5 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 2 Jul 2025. 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?
Number of steps per day, during 7 days at 3 months of the AUS activation (time frame: Through the study completion, an average of 8 months). 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 2 Jul 2025.