Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

February 16, 2026 updated by: InnoCon Medical

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study

UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). 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, multi-centre, and early feasibility study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 40 female patients with OAB/BD over a period of 12 weeks.

The investigation consists of two periods: a screening period and an intervention period.

During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period.

During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Peter Christensen, MD
          • Phone Number: +45 20375471
          • Email: petchris@rm.dk
        • Principal Investigator:
          • Jakob Jakobsen, MD
      • Herlev, Denmark, 2730
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant is female
  2. Participant is ≥ 18 years of age.

  3. Participant is diagnosed with OAB or BD.

    OAB: Urinary urgency usually with one or more of the following:

    i. Urinary urgency incontinence (≥1 per/week). ii. Urinary frequency (≥8 voiding/day without polyuria). iii. Nocturia (≥2 voiding/night without nocturnal polyuria).

    BD: One or more of the following:

    i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.

    ii. Faecal incontinence (urge/passive) (≥1 per/week).

  4. 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, apart from the OAB or BD, 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 devices (any medical device that uses electrical energy or other sources 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 clinical investigation.
  5. Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.
  6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
  7. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
  8. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.

  9. Participant does not speak or understand Danish.

    • The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical stimulation
Electrical stimulation to the dorsal genital nerve.
Device: UCon-Bar
The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar electrode
Other Names:
  • Electrical stimulation to the dorsal genital nerve (DGN stimulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.
Time Frame: After 4 weeks and 12 weeks
1) Number and severity of adverse events during insertion of the UCon Bar Electrode: Excessive pain and excessive bleeding. 2) Number and severity of adverse events after insertion: Infection, pain, and bleeding. 3) Number of participants with successful insertion with no premature removal of the Bar Electrode.
After 4 weeks and 12 weeks
PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms
Time Frame: Change from baseline at 4 weeks and/or 12 weeks
Ratio of participants with at least 50% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.
Change from baseline at 4 weeks and/or 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SECONDARY SAFETY: Characterization, including frequency and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon-Bar Electrode.
Time Frame: After 4 weeks and 12 weeks
1) Characterization of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.2) Number of participants experiencing adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.3) Number and severity of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.
After 4 weeks and 12 weeks
SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms
Time Frame: Change from baseline at 4 weeks and/or 12 weeks
Ratio of participants with at least 33% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.
Change from baseline at 4 weeks and/or 12 weeks
SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience a change in their quality of life
Time Frame: Change from baseline at 4 weeks and/or 12 weeks
Ratio of subjects with a change in their self-reported quality of life measures as assessed by specific QoL questionnaires related to OAB (ICIQ-OAB, an overall score with greater values indicates increased symptom severity) or BD (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 4 weeks and/or 12 weeks
SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience an impression of treatment improvement
Time Frame: After 4 week screening period, 4 weeks, and 12 weeks
Ratio of participants with a self-reported improvement in their impression of treatment as assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. An improvement is defined as choosing one of the following: very much, better, much better, or a little better.
After 4 week screening period, 4 weeks, and 12 weeks
SECONDARY PERFORMANCE: ratio of participant that accept UCon and DGN stimulation [Device and treatment acceptability of UCon]
Time Frame: After 4 week screening period, 4 weeks, and 12 weeks
Ratio of participants that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation periods (with UCon Patch Electrode and UCon Bar Electrode) .
After 4 week screening period, 4 weeks, and 12 weeks
Secondary PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms during the screening period can be reproduced in the intervention period.
Time Frame: Change from screening period at 4 weeks and/or 12 weeks
Ratio of participants with at least 50% reduction in symptoms using the UCon-Patch Electrode, that can be reproduced in 80% of the participants using the UCon Bar Electrode.
Change from screening period at 4 weeks and/or 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnoCon Medical

Collaborators

Odense University Hospital
Aarhus University Hospital
Herlev Hospital

Investigators

  • Principal Investigator: Peter Christensen, MD, Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK_FEAS_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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