serfriendliness and usability of the Dfree ultrasonic sensor to support participation and autonomy of people with with incontinence problems: a mixed-method study.

Not Applicable

• Conditions: N31.1; N31.2; Reflex neuropathic bladder, not elsewhere classified; Flaccid neuropathic bladder, not elsewhere classified

• Registration Number: DRKS00020764
• Lead Sponsor: MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-05
• Study Completion: 2021-12-08
• Results First Posted: 2022-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age =18 years
• incontinence
• Urologically confirmed detrusor hypotonia
• Significant suffering

Exclusion Criteria

• existing urinary tract infection
• bladder- catheter
• Detrusorhypertonus
• Difficult micturition
• haematuria
• dementia
• Immobility (min. 50 m walking distance).
• Inability to get up from a sitting position
• Life expectancy less than 3 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary target parameter is the perceived change in the subjectively recognized QoL for the urinary incontinence symptom caused by detrusor hypotonia while using the Dfree sensor. The change in the average scores is considered. The KHQ is helpful to determine the detailed status of the QoL of older men and women [...] who suffer from urinary bladder incontinence (Okamura et al. 2002, p. 411). The KHQ was selected to determine the primary target parameter because it guarantees a comprehensive and valid assessment of micturition satisfaction.

Secondary Outcome Measures

Name	Time	Method
Another secondary target parameter is the number of successful toilet visits without involuntary urination. <br><br>The following endpoints are also taken into account as secondary target parameters:<br><br>• Reported therapy adherence<br>• Functional status<br>• Self-reporting degree of autonomy<br>• Subjectively perceived improvement in the quality of care<br><br>The effect of using the Dfree sensor is observed over time until the end of the observation period or application of another therapeutic intervention.