UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.
Subject is ≥ 18 years of age.
Subject is male.
Subject is diagnosed with OAB
Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.
Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
Crossover
Urge stimulation
DeviceParticipants will receive stimulation for 60 seconds, when they feel an urgency.
Time limited stimulation
DeviceParticipant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
Ratio of subjects with at least 50% change in their OAB symptoms from baseline. Participants shall complete a 3-day bladder diary to report their symptoms. The symptoms related to OAB: * 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.
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. Subjects will report on any experience associated with the use of UCon.
SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.
Severity of adverse events and anticipated adverse device effects.The severity will be evaluated from the subjects' report on any experience associated with the use of UCon.
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Ratio of subjects with a change in their OAB quality of life measures as assessed by specific QoL questionnaires related to OAB condition (ICIQ-OAB, AOBq). An overall score with greater values indicates a worse symptom outcome.
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.
Ratio of subjects with a change in their treatment outcome (i.e. symptoms) assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. Higher scores indicates a worse treatment outcome.
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