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UCon Treatment of the Symptoms of Faecal Incontinence (FI)

Primary Purpose

Faecal Incontinence, Faecal Incontinence With Faecal Urgency

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
UCon
Sponsored by
InnoCon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Faecal Incontinence focused on measuring Faecal Incontinence, Faecal Urgency, Neurostimulation, Dorsal Genital Nerve, Frequent bowel movements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Vall d'Hebron University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Electrical stimulation to the dorsal genital nerve.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 9, 2023
Last Updated
August 15, 2023
Sponsor
InnoCon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05864807
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoCon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence, Faecal Incontinence With Faecal Urgency
Keywords
Faecal Incontinence, Faecal Urgency, Neurostimulation, Dorsal Genital Nerve, Frequent bowel movements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Electrical stimulation to the dorsal genital nerve.
Intervention Type
Device
Intervention Name(s)
UCon
Intervention Description
The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon
Primary Outcome Measure Information:
Title
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
Description
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
Time Frame
After 28 days (4 weeks)
Title
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of FI symptoms in a home setting.
Description
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
Time Frame
Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)
Secondary Outcome Measure Information:
Title
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Description
Number of subjects experiencing adverse events and anticipated adverse device effects associated with the use of UCon.
Time Frame
After 28 days (4 weeks)
Title
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Description
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.
Time Frame
Change from baseline at 28 days (4 weeks) and 56 days (8 weeks, end of study)
Title
SECONDARY PERFORMANCE: To evaluate the ratio of subject that accept UCon and DGN stimulation [Device and treatment acceptability of UCon].
Description
Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.
Time Frame
After 28 days (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianna Mærsk Knudsen
Phone
40517712
Ext
+45
Email
dmk@innoconmedical.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eloy Espin Basany, MD
Organizational Affiliation
Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eloy Espin Basany, MD
Phone
676531898
Ext
+34
Email
espin@vhebron.net

12. IPD Sharing Statement

Learn more about this trial

UCon Treatment of the Symptoms of Faecal Incontinence (FI)

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