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Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation (AP-SU)

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ClinicalTrials.gov Identifier: NCT04008108
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Activity sensor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient with urinary incontinence
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.




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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 ]

    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).


  2. Other activity sensor data (heart rate) [ Time Frame: Through the study completion, an average of 8 months ]

    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).


  3. Other activity sensor data (sedentary and activity percentage in the day) [ Time Frame: Through the study completion, an average of 8 months ]

    Sedentary and activity perrcentage 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).


  4. Incontinence Quality of Life (I-QOL) [ Time Frame: Through the study completion, an average of 8 months ]

    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).


  5. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Through the study completion, an average of 8 months ]

    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).


  6. PAD-test / 24h [ Time Frame: Through the study completion, an average of 8 months ]

    PAD-test / 24h perfomed 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 curatorship
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008108


Contacts
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Contact: Pierre MOZER, PU-PH 01 42 17 72 97 ext +33 pierre.mozer@aphp.fr
Contact: Anne DENORMANDIE, resident 01 42 27 78 44 ext +33 anne.denormandie@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Pierre MOZER, PU-PH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04008108     History of Changes
Other Study ID Numbers: APHP190234
2019-A00680-57 ( Other Identifier: ANSM )
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
urinary incontinence
artificial urinary sphincter
physcial activity
number of steps per day
activity tracker
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders