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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020764

Enrollment

Registered

2020-02-05

Start date

2020-06-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N31.1 N31.2

Interventions

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 co

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Contacts

Public ContactSebastian Hofstetter

MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt

sebastian.hofstetter@medizin.uni-halle.de0345 557 4064

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026