Treatment of Overactive Bladder and Bowel Dysfunction with UCon Bar Electrode

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

This study is testing a new device to see if it can help women with overactive bladder and bowel issues feel better by using electrical stimulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: InnoCon Medical (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 3 sites (Aarhus and 2 other locations)
• Trial ID: NCT06091566 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and performance of the UCon Bar Electrode, a medical device designed to treat symptoms of overactive bladder (OAB) and bowel dysfunction (BD) through electrical stimulation of the dorsal genital nerve. The study involves a cohort of 40 female patients who will undergo a screening period using a Patch Electrode followed by an intervention period with the Bar Electrode. Participants will use the device at home for either 4 or 12 weeks after a recovery period. The goal is to assess the device's effectiveness in reducing symptoms related to urinary and fecal incontinence.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 and older diagnosed with overactive bladder or bowel dysfunction.

Not a fit: Patients who are medically unstable or have active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from overactive bladder and bowel dysfunction.

How similar studies have performed: Other studies have shown promise with neurostimulation approaches for similar conditions, indicating potential for success in this novel application.

Eligibility criteria

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.

Where this trial is running

Aarhus and 2 other locations

• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• Herlev Hospital — Herlev, Denmark (Recruiting)
• Odense University Hospital — Odense, Denmark (Recruiting)

Study contacts

• Principal investigator: Peter Christensen, MD — Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
• Study coordinator: Dianna Mærsk Knudsen

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