Clinical trial NCT04008108: Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
artificial urinary sphincter
physical activity
number of steps per day
activity tracker
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of steps per day, during 7 days at 3 months of the AUS activation
timeFrame: Through the study completion, an average of 8 months
Secondary outcomes:
measure: Number of steps per day, during 7 days, at 1 month of the AUS activation
timeFrame: Through the study completion, an average of 6 months
measure: Other activity sensor data (heart rate)
timeFrame: Through the study completion, an average of 8 months
measure: Other activity sensor data (sedentary and activity percentage in the day)
timeFrame: Through the study completion, an average of 8 months
measure: Incontinence Quality of Life (I-QOL)
timeFrame: Through the study completion, an average of 8 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Through the study completion, an average of 8 months
measure: PAD-test / 24h
timeFrame: Through the study completion, an average of 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Urologie, Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre MOZER, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: