Faecal IncontinenceNCT05864807
UCon Treatment of the Symptoms of Faecal Incontinence (FI)
A study testing UCon in people with Faecal Incontinence and Faecal Incontinence With Faecal Urgency, run by InnoCon Medical at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Faecal Incontinence With Faecal Urgency
- What is being tested?
- UCon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- UCon
- Keywords
- Faecal Incontinence, Faecal Urgency, Neurostimulation, Dorsal Genital Nerve, Frequent bowel movements
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UConDevice
The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Electrical stimulation to the dorsal genital nerve. Receives: Device: UCon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Number of subjects experiencing adverse events and anticipated adverse device effects associated with the use of UCon.
Measured: 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.
Measured: 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.
Measured: After 28 days (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Aug 2023
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoCon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eloy Espin Basany, MD, Principal investigator, Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864807
- Sponsor's protocol ID
- ES_FEAS_01
- Status last verified
- Feb 2026
- First submitted
- 9 May 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of UCon for the Treatment of the Symptoms of Faecal Incontinence (FI) - An Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05864807
- Acronym / sponsor ID
- ES_FEAS_01
- Keywords
- Faecal Incontinence, Faecal Urgency, Neurostimulation, Dorsal Genital Nerve, Frequent bowel movements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- InnoCon MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: UConElectrical stimulation to the dorsal genital nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UConThe participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon | Device | Interventional arm |
Primary outcome
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting.
Time frame: After 28 days (4 weeks)
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.
Time frame: Change from baseline at 28 days (4 weeks) and 42 days (6 weeks)
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
3 secondary outcomes
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Time frame: After 28 days (4 weeks)
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Time frame: 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].
Time frame: After 28 days (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloy Espin Basany, MD principal investigator
Vall d'Hebron University Hospital, 119, 08035 Barcelona, Spanien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCon in people with Faecal Incontinence and Faecal Incontinence With Faecal Urgency, run by InnoCon Medical at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of the symptoms of FI in a home setting. (time frame: After 28 days (4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.