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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00020764
• Date of registration: 05/02/2020
• Prospective Registration: Yes
• Primary sponsor: MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt
• Public title: Userfriendliness and usability of the Dfree ultrasonic sensor to support participation and autonomy of people with with incontinence problems: a mixed-method study.
• Scientific title: Userfriendliness and usability of the Dfree ultrasonic sensor to support participation and autonomy of people with with incontinence problems: a mixed-method study. - Dfree
• Date of first enrolment: 25/06/2020
• Target sample size: 20
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00020764
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Sebastian Hofstetter
• Affiliation: MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt

• Name: Sebastian Hofstetter
• Affiliation: MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

N31.2

N31.1

Reflex neuropathic bladder, not elsewhere classified

N31.1
N31.2

Flaccid neuropathic bladder, not elsewhere classified

Intervention(s)

Group 1: 20 patients with with incontinence problems use the Dfree ultrasound sensor 12hours/day during a period of 3 month. At the measurement times T0 (before intervention begins) and T1 (after completion of the intervention period) they will be asked about their OoL using the questionnaire KHQ. In addition, satisfaction with the treatment was assessed by the ZUF-8 questionnaire and supported by a guided interview.

Primary Outcome(s)

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(s)

Another secondary target parameter is the number of successful toilet visits without involuntary urination.

The following endpoints are also taken into account as secondary target parameters:

• Reported therapy adherence
• Functional status
• Self-reporting degree of autonomy
• Subjectively perceived improvement in the quality of care

The effect of using the Dfree sensor is observed over time until the end of the observation period or application of another therapeutic intervention.

Source(s) of Monetary Support

Ministerium der Finanzen des Landes Sachsen-Anhalt und EU Verwaltungsfond für die ESIF in Sachsen-Anhalt

Ethics review

Status: Approved
Approval date: 20/12/2019
Contact:

[e-mail]

Ethik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 12/01/2023
• Date Completed: 08/12/2021
• URL: http://drks.de/search/en/trial/DRKS00020764#studyResults