UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study

Conditions
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Faecal Incontinence, Faecal Incontinence With Faecal Urgency

Intervention / Treatment
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* Device: UCon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥ 18 years of age. Participant is showing symptoms of FI. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home. Exclusion Criteria: Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation). Participant has an active infection in the genital area. Participant has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function). Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception* during the interventional period judged by the investigator. Participant is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks to enrolment. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation, e.g., denervated patients and severe diabetic neuropathy. Participant is currently receiving cancer treatment. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs. Participant does not speak and understand Spanish. The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional arm<br>Electrical stimulation to the dorsal genital nerve. | Device: UCon<br>* The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRIMARY 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. | 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 | Change from baseline at 28 days (4 weeks) and 42 days (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | After 28 days (4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Faecal Incontinence, Faecal Urgency, Neurostimulation, Dorsal Genital Nerve, Frequent bowel movements