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

NCT06091566 | Recruiting

• 1 other identifier: DK_FEAS_02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Fecal Incontinence; Fecal Incontinence With Fecal Urgency; Nocturia; Urinary Frequency More Than Once at Night; Bowel Disorders Functional; Incontinence, Nighttime Urinary

Keywords

Urinary Incontinence; Fecal Incontinence; Urge incontinence; Neurostimulation; Dorsal Genital Nerve

Outcome Measures

Primary Outcomes (2)

• PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.

  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

  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 Outcomes (6)

• 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.

  After 4 weeks and 12 weeks

• SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms

  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

  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

  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]

  After 4 week screening period, 4 weeks, and 12 weeks

Study Arms (1)

Electrical stimulation

EXPERIMENTAL

Electrical stimulation to the dorsal genital nerve.

Device: UCon-Bar

Interventions

UCon-Bar DEVICE

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

Also known as: Electrical stimulation to the dorsal genital nerve (DGN stimulation)

Electrical stimulation

Eligibility Criteria

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

You may qualify if:

• Participant is female
• Participant is ≥ 18 years of age.
• 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).
• 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, apart from the OAB or BD, 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 devices (any medical device that uses electrical energy or other sources 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 clinical investigation.
• 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.
• Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
• Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
• Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• 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.

Sponsors & Collaborators

• Herlev Hospital: collaborator
• Aarhus University Hospital: collaborator
• InnoCon Medical: lead
• Odense University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Urge; Fecal Incontinence; Nocturia; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Peter Christensen, MD

  Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dianna Mærsk Knudsen

CONTACT

40517712; dmk@innoconmedical.dk

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: October 16, 2023
• First Posted: October 19, 2023
• Study Start: January 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)