G82.50 G82.20 G95.80 G95.81 G95.82 N31
Conditions
Interventions
Group 1: One arm with baseline phase and intervention phase thereafter
An intra-individual control will be performed: First, (conventional) bladder emptying management will be documented using mictur
Sponsors
Krankenhaus Rummelsberg
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Neurogenic bladder dysfunction without sensory bladder feedback Adults (18-99) Use of intermittent catheterization Successful get-to-know phase of the inContAlert BladderMate Capacity to consent Written consent of the patient to participate in the clinical trial
Exclusion criteria
Exclusion criteria: Pregnancy Skin disease in the area where the sensor contacts the skin Psychiatric disorders Inability to consent BMI > 40 In ambulatory setting: Unavailability of a smartphone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of bladder distentions (explorative, emptied micturition volume > 500 ml) | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact on quality of life (assessed using the Qualiveen questionnaire) Impact on working conditions for nursing staff (only in a hospital context, assessed using the SUS questionnaire and semi-structured interviews) User-friendliness (assessed using the SUS questionnaire) Number of incontinence incidents when using the system compared to the situation without using the system | — |
Countries
Germany
Contacts
Public ContactMatthias Ponfick
Krankenhaus Rummelsberg
Outcome results
None listed