Clinical trial NCT05864807: UCon Treatment of the Symptoms of Faecal Incontinence (FI)
Official title: Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Faecal Incontinence
Faecal Incontinence With Faecal Urgency
Keywords: Faecal Incontinence
Faecal Urgency
Neurostimulation
Dorsal Genital Nerve
Frequent bowel movements
Lead sponsor: InnoCon Medical
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Participant is ≥ 18 years of age.
2. Participant is showing symptoms of FI.
3. 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:

1. Participant is medically unstable (acute illness or complication of a chronic condition that might affect the participants´ participation in the investigation).
2. Participant has an active infection in the genital area.
3. 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).
4. 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.
5. 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.
6. 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.
7. Participant is currently receiving cancer treatment.
8. Participant has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
9. 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.

Primary outcomes:
measure: PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
timeFrame: After 28 days (4 weeks)
measure: PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of FI symptoms in a home setting.
timeFrame: Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)
Secondary outcomes:
measure: SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
timeFrame: After 28 days (4 weeks)
measure: SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
timeFrame: Change from baseline at 28 days (4 weeks) and 56 days (8 weeks, end of study)
measure: SECONDARY PERFORMANCE: To evaluate the ratio of subject that accept UCon and DGN stimulation [Device and treatment acceptability of UCon].
timeFrame: After 28 days (4 weeks)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
Study officials:
affiliation: Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien
name: Eloy Espin Basany, MD
role: PRINCIPAL_INVESTIGATOR
References: