Safety and Performance of UCon Patch Electrode

NCT06754189 | Recruiting

• 1 other identifier: DK_PIVO_01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g., suppressing undesired bladder/bowel activity to relieve the symptoms of the patient. This pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Incidence of serious adverse device effects (SADEs).

  Number of SADEs.

  At 12 weeks.

• Ratio of treatment change [performance] of OAB symptoms.

  Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urinary Urgency (UU) voids (with or without Urgency Urinary Incontinence, UUI).

  Change from baseline at 6 weeks.

• Ratio of treatment change [performance] of BD symptoms.

  Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Faecal Urgency (FU) episodes OR at least a 50% reduction in Faecal Incontinence (FI) episodes.

  Change from baseline at 6 weeks.

Secondary Outcomes (6)

• Incidence and severity of adverse events (AEs).

  At 12 weeks.

• Ratio of treatment change [performance] of Urgency Urinary Incontinence.

  Change from baseline at 6 weeks.

• Self-reported quality of life measures as assessed by the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) questionnaire.

  Change from baseline at 6 weeks.

• Faecal Urgency (FU) episodes.

  Change from baseline at 6 weeks.

• Faecal Incontinence (FI) episodes.

  Change from baseline at 6 weeks.

Study Arms (2)

Treatment group

EXPERIMENTAL

Electrical stimulation (Time Limited stimulation) to the dorsal genital nerve.

Device: Time Limited stimulation

Sham group

SHAM COMPARATOR

Sham stimulation to the dorsal genital nerve.

Device: Sham stimulation

Interventions

Time Limited stimulation DEVICE

The participant self-administer 30 min. of electrical stimulation using Time Limited stimulation to the dorsal genital nerve (DGN) for 6 weeks using UCon with the UCon-Patch electrode.

Also known as: UCon-Patch

Treatment group

Sham stimulation DEVICE

The participant self-administer 30 min. of sham stimulation to the dorsal genital nerve (DGN) for 6 weeks using a sham device with the UCon-Patch electrode.

Also known as: UCon-Sham

Sham group

Eligibility Criteria

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

You may qualify if:

• Participant is ≥ 18 years of age.
• Participant is diagnosed with OAB or BD.
• Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.

You may not qualify if:

• Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.
• Participant has an active infection in the genital area, including skin infections.
• Participant has injured or irritated skin in the genital area, where the electrode is placed.
• Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).
• 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, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception\* during the clinical investigation.
• Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.
• Participant has previously participated in a clinical investigation with UCon.
• Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.
• Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.
• Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
• Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation.
• Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
• The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.
• Participant is planning or has a scheduled surgery/diagnostic procedure (within the duration of their participation) for any condition, that would require catheterization. Or have a prolonged hospitalization that would affect the ability to complete the stimulation.

Sponsors & Collaborators

• InnoCon Medical: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Herlev 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; Nocturia; Nocturnal Enuresis; Fecal Incontinence

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; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to a treatment group and a sham group.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

DK (3)