UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Faecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05864807
• Other study ID #: ES_FEAS_01
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2023
• Source: InnoCon Medical
• Contact: Dianna Mærsk Knudsen
• Phone: 40517712
• Email: dmk[@]innoconmedical.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Faecal Incontinence
• Faecal Incontinence With Faecal Urgency
• Fecal Incontinence

Intervention

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

Locations

Country	Name	City	State
Spain	Vall d'Hebron University Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
InnoCon Medical

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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)