This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (DGN) through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.
The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD will need to be enrolled at the investigational sites to account for screening attrition and dropouts. Screening and baseline measurements includes a 7-days bladder diary (OAB) / 14-days bowel diary (BD) and quality-of-life measures. Following the screening and baseline measurements, the subjects will be introduced and trained on how to set up and use UCon. For 1 month the subjects will use UCon at home and complete a daily bladder/bowel diary and a stimulation diary. After completion of the interventional period, subjects will fill out the quality-of-life measures once again.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon
Aarhus University Hospital
Aarhus, Aarhus N, Denmark
Herlev Hospital
Herlev, Region Sjælland, Denmark
Odense University Hospital
Odense, Denmark
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Time frame: After 4 and 12 weeks of stimulation (end of study).
Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.
Urinary urgency is measured by number of urgency episodes/day. Urinary frequency is measured by number of voidings/day. Urgency urinary incontinence is measured by number of leaks preceded by urgency/day. Nocturia is measured by number of voidings/night. Faecal urgency is measured by number of urgency episodes/day. Frequent bowel movements are measured by number of voidings/day. Faecal incontinence (urge/passive) is measured by number of leaks/day.
Time frame: Change from baseline OAB/BD symptoms at 4 and 12 weeks.
Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
Number of subjects experiencing adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period. Number and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.
Time frame: After 4 and 12 weeks of stimulation (end of study).
Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.
For OAB the following is used to assess QoL: "International Consultation on Incontinence Questionnaire Overactive Bladder Module". It contains 4 questions and a higher total score means a worse outcome. For BD a combination of the following is used to assess QoL: "St. Marks incontinence score" and "Rockwood Fecal Incontinence Quality of Life Scale". St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome. The Rockwood Fecal Incontinence Quality of Life Scale contains 29 questions and a higher total score means a worse outcome.
Time frame: Change from baseline QoL at 4 and 12 weeks.
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