Treatment for symptoms of fecal incontinence

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

This study is testing a new device that uses electrical stimulation to see if it can help Spanish patients with fecal incontinence feel better over four weeks.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: InnoCon Medical (Industry-sponsored)
• Locations: 1 site (Barcelona)
• Trial ID: NCT05864807 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the UCon medical device, which electrically stimulates the dorsal genital nerve to modulate bladder and bowel activity. Conducted as a single-arm, prospective, single-centre feasibility study, it aims to assess the initial safety and performance of the device in Spanish patients experiencing fecal incontinence. Participants will use the device over a treatment period of four weeks, providing feedback on their symptoms and device usability.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who exhibit symptoms of fecal incontinence.

Not a fit: Patients with active infections, implanted medical devices, or those who are pregnant or nursing may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fecal incontinence.

How similar studies have performed: While this approach is innovative, similar studies using neurostimulation for bladder and bowel control have shown promise, indicating potential for success.

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.

Where this trial is running

Barcelona

• Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Eloy Espin Basany, MD — Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien
• Study coordinator: Dianna Mærsk Knudsen

Conditions Faecal Incontinence; Faecal Incontinence With Faecal Urgency; Faecal Urgency; Neurostimulation; Dorsal Genital Nerve; Frequent bowel movements