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.
The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Maastricht University Medical Center+
Maastricht, Netherlands
RECRUITINGPRIMARY 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.
Time frame: After 44 days (end of study)
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.
Time frame: Change from baseline at 14 days, 30 days and 44 days (study end)
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.
Time frame: After 44 days (end of study)
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.
Time frame: After 44 days (study end)
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.
Time frame: Change from baseline at 14 days and 44 days (end of study)
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.
Time frame: Change from baseline at 14 days and 44 days (end of study)
SECONDARY PERFORMANCE: To evaluate the 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.
Time frame: After 44 days (study end)
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