Trial document



drksid header

  DRKS00020764

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Dfree

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Study to evaluate an increase in quality of life and participation in everyday life by using a Japanese ultrasonic sensor, the Dfree. The device promises to solve incontinence problems in everyday life and thus to enable participation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The ultrasound device Dfree is a technical artifact for predicting the need for micturition, to support people having difficulties in controlling micturition. The Dfree sensor is recommended as a new social assistive care technology for accompanying therapy by urinary incontinence. At the moment, however, it is still unclear whether the Dfree offers advantages over previously established therapeutic approaches. The building blocks of conservative therapy for urinary bladder incontinence include, for example, drinking and micturition training, physiotherapy, electrostimulation and drug intervention therapies with cholinergics or alpha blockers or therapy using bladder pacemakers (Bump et al. 1991; Füsgen 2005; Klingler 2007, p. 10; ders., 2014 ; Borello-France et al. 2013; Huang et al. 2019). In addition, the supply of catheter systems in the sense of long-term catheterization as well as operative therapies for bladder emptying disorders and urinary incontinence (Eberhardt and Geissbühler 2000, 44 f .; Jost 2014) are relevant. The Dfree has the potential to minimize problems resulting from urinary incontinence in an uncomplicated and simple manner. However, there is currently no evidence of user-friendliness and usability. In particular, actually there are no studies available to assess the applicability of the Dfree ultrasound device in older people with urinary incontinence, or studies to change or improve the quality of life and improved ability to participate in everyday life. This needs to be evaluated.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00020764
  •   2020/02/05
  •   [---]*
  •   yes
  •   Approved
  •   2019-133, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N31.1 -  Reflex neuropathic bladder, not elsewhere classified
  •   N31.2 -  Flaccid neuropathic bladder, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   30 patients with detrusor hypotension 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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/03/12
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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
• Participation in other urological-therapeutic intervention

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt
    • Mr.  M.A.  Sebastian  Hofstetter 
    • Magdeburger Str. 12
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum Halle, Klinik und Poliklinik für Urologie
    • Ms.  Dr. med.  Sandra  Schönburg 
    • Ernst-Grube-Str. 40
    • 06120  Halle (Saale)
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt
    • Mr.  M.A.  Sebastian  Hofstetter 
    • Magdeburger Str. 12
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt
    • Mr.  M.A.  Sebastian  Hofstetter 
    • Magdeburger Str. 12
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • MLU Halle-Wittenberg, Med. Fak.; DELH; FORMAT-Projekt
    • Mr.  M.A.  Sebastian  Hofstetter 
    • Magdeburger Str. 12
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.