UCon is a medical device for treatment of the symptoms of overactive bladder and fecal incontinence (FI). It electrically stimulates the 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. This clinical investigation is designed as a single-arm, prospective, single-centre, early feasibility study.
The overall purpose of the current clinical investigation is to evaluate the medical device (UCon) with respect to initial safety and device performance in a cohort of Spanish patients with FI over a treatment period of 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon
Vall d'Hebron University Hospital
Barcelona, Spain
RECRUITINGPRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
Time frame: After 28 days (4 weeks)
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of FI symptoms in a home setting.
Ratio of subjects with at least 50% improvement of their FI symptoms from baseline. Participants shall complete an electronic bowel diary to report their symptoms
Time frame: Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Number of subjects experiencing adverse events and anticipated adverse device effects associated with the use of UCon.
Time frame: After 28 days (4 weeks)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Ratio of subjects with a change in their self-reported quality of life measures as assessed by specific QoL questionnaires related to FI condition (St. Marks incontinence score and Rockwood Fecal Incontinence Quality of Life Scale). An overall score with greater values indicates a worse symptom outcome.
Time frame: Change from baseline at 28 days (4 weeks) and 56 days (8 weeks, end of study)
SECONDARY PERFORMANCE: To evaluate the ratio of subject that accept UCon and DGN stimulation [Device and treatment acceptability of UCon].
Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: After 28 days (4 weeks)