An interventional study of Activity sensor in Urinary Incontinence, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
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 :
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 45 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient with urinary incontinence
Other: Activity sensor
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.
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).
Time frame: Through the study completion, an average of 8 months
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Through the study completion, an average of 8 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris