Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation (AP-SU)
Primary Purpose
Urinary Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Activity sensor
Sponsored by
About this trial
This is an interventional other trial for Urinary Incontinence focused on measuring urinary incontinence, artificial urinary sphincter, physical activity, number of steps per day, activity tracker
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
Sites / Locations
- Service d'Urologie, Hôpital Pitié-SalpêtrièreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with urinary incontinence
Arm Description
Patient with urinary incontinence
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT04008108
First Posted
April 15, 2019
Last Updated
February 8, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04008108
Brief Title
Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
Acronym
AP-SU
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
July 29, 2023 (Anticipated)
Study Completion Date
January 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, artificial urinary sphincter, physical activity, number of steps per day, activity tracker
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with urinary incontinence
Arm Type
Experimental
Arm Description
Patient with urinary incontinence
Intervention Type
Other
Intervention Name(s)
Activity sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of steps per day, during 7 days at 3 months of the AUS activation
Description
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
Secondary Outcome Measure Information:
Title
Number of steps per day, during 7 days, at 1 month of the AUS activation
Description
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
Title
Other activity sensor data (heart rate)
Description
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
Title
Other activity sensor data (sedentary and activity percentage in the day)
Description
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
Title
Incontinence Quality of Life (I-QOL)
Description
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
Title
International Physical Activity Questionnaire (IPAQ)
Description
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
Title
PAD-test / 24h
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre MOZER, PU-PH
Phone
01 42 17 72 97
Ext
+33
Email
pierre.mozer@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne DENORMANDIE, resident
Phone
01 42 27 78 44
Ext
+33
Email
anne.denormandie@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre MOZER, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Urologie, Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre MOZER
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation
We'll reach out to this number within 24 hrs