UCon Treatment of the Symptoms of Faecal Incontinence (FI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Faecal Incontinence; Faecal Incontinence With Faecal Urgency
• Intervention / Treatment: Device: UCon

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dianna Mærsk Knudsen; Phone Number: +45 40517712; Email: dmk@innoconmedical.dk

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Vall d'Hebron University Hospital
    • Contact: Eloy Espin Basany, MD; Phone Number: +34 676531898; Email: espin@vhebron.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: InnoCon Medical
• Investigators: Principal Investigator: Eloy Espin Basany, MD, Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neurostimulation; Faecal Incontinence; Dorsal Genital Nerve; Faecal Urgency; Frequent bowel movements
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: ES_FEAS_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No