Variation of Physical Activity, Measured by the Number of Steps Per Day, After Artificial Urinary Sphincter Implantation

NCT ID: NCT04008108

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2023-10-24

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with urinary incontinence

Patient with urinary incontinence

Group Type: EXPERIMENTAL

Activity sensor

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre MOZER, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service d'Urologie, Hôpital Pitié-Salpêtrière

Paris, , France

Countries

France

Other Identifiers

2019-A00680-57

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190234

Identifier Type: -

Identifier Source: org_study_id