UCon Treatment of the Symptoms of Faecal Incontinence (FI)

NCT05864807 | Completed

• 1 other identifier: ES_FEAS_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Faecal Incontinence With Faecal Urgency; Faecal Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.

  After 28 days (4 weeks)

• SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.

  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].

  After 28 days (4 weeks)

Study Arms (1)

Interventional arm

EXPERIMENTAL

Electrical stimulation to the dorsal genital nerve.

Device: UCon

Interventions

UCon DEVICE

The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InnoCon Medical: lead

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Eloy Espin Basany, MD

  Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: August 1, 2023
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

ES (1)