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

NCT04008108 | Completed

• 2 other identifiers: APHP1902342019-A00680-57
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; artificial urinary sphincter; physical activity; number of steps per day; activity tracker

Outcome Measures

Primary Outcomes (1)

• 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).

  Through the study completion, an average of 8 months

Secondary Outcomes (6)

• Number of steps per day, during 7 days, at 1 month of the AUS activation

  Through the study completion, an average of 6 months

• Other activity sensor data (heart rate)

  Through the study completion, an average of 8 months

• Other activity sensor data (sedentary and activity percentage in the day)

  Through the study completion, an average of 8 months

• Incontinence Quality of Life (I-QOL)

  Through the study completion, an average of 8 months

• International Physical Activity Questionnaire (IPAQ)

  Through the study completion, an average of 8 months

Study Arms (1)

Patient with urinary incontinence

EXPERIMENTAL

Patient with urinary incontinence

Other: Activity sensor

Interventions

Activity sensor 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.

Patient with urinary incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'Urologie, Hôpital Pitié-Salpêtrière

Paris, France

Location

MeSH Terms

Conditions

Urinary Incontinence; Motor Activity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Pierre MOZER, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: July 5, 2019
• Study Start: July 29, 2019
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)