Safety and Performance of UCon Patch Electrode

Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Fecal Incontinence; Urinary Incontinence, Urge; Nocturia; Fecal Incontinence With Fecal Urgency; Urinary Frequency More Than Once at Night; Incontinence, Nighttime Urinary; Urinary
• Intervention / Treatment: Device: Time Limited stimulation; Device: Sham stimulation

Detailed Description

The overall purpose of this pivotal clinical investigation is to evaluate the UCon device with a Patch Electrode with respect to clinical safety and device performance in a cohort of 180 patients with OAB/BD over a period of 12 weeks.

The participants participate in a 12-week intervention period. For weeks 1-6, participants will be randomized (2:1 randomization) to either a treatment group using UCon-Patch with Time Limited stimulation or a sham group using UCon-Sham with sham stimulation. Participants in the treatment group will receive the actual stimulation with the intent of improving their symptoms, whereas those in the sham group will receive sham stimulation for short periods of time believed not to be capable of improving their symptoms.

For weeks 7-12 of the intervention periods, the treatment group has the opportunity to add Urge stimulation to the Time Limited stimulation, while the sham group shifts to using UCon-Patch Time Limited stimulation.

To assess the safety and performance of the UCon device on equal terms with similar devices in the market, the full intervention period with UCon will be conducted over 12 weeks, evaluating safety aspects of UCon on longer terms and confirming continued effects after 6 weeks in the treatment group. Additional analyses on data related to primary and secondary endpoints with safety and performance data from the 12-week follow-up will also be performed, but the primary analysis will focus on baseline and 6-week follow-up data.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dianna Mærsk Knudsen; Phone Number: +45 40517712; Email: dmk@innoconmedical.dk

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
    • Recruiting
    • Herlev Hospital
    • Contact: Niels Klarskov, MD; Phone Number: +45 38681406; Email: Niels.Klarskov@regionh.dk
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Mark Bremholm Ellebæk, MD; Phone Number: +45 40880511; Email: Mark.Ellebaek1@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Exclusion Criteria specific for OAB:

• 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.
• Participant (male) has symptoms of bladder outlet obstruction, e.g., caused by benign prostatic hyperplasia or prostate cancer.
• Participant has polyuria or symptoms of polyuria.
• Participant has a current or reoccurring urinary tract infection (≥3 or more within the previous 12 months or ≥2 within the previous 6 months).
• Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixed incontinence with SUI likely to confound outcome measures.
• Participant has Bladder Pain Syndrome or interstitial cystitis.
• Participant has had botulinum toxin (BOTOX) treatment in the pelvic region within 9 months or has lasting benefit from BOTOX.
• Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2 years.
• Participants who demonstrate detrusor overactivity on a urodynamic test can be included.
• Participant has used antimuscarinics or β3 agonists within 2 weeks.
• Participant has started oestrogen therapy within 3 months or are planning to stop therapy when enrolled in the clinical investigation.

Exclusion Criteria specific for BD:

• Participant is planning or has a scheduled surgery/diagnostic procedure (within the duration of their participation), for any condition, that would influence their bowel movements (e.g., injection of bulking agents, radiofrequency energy, or ligation of haemorrhoids). Or have a prolonged hospitalization that would affect the ability to complete the stimulation.
• Participant is currently being treated with antibiotics.
• Participant has a history of uncontrolled diarrhoea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale).
• Participant has a history of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale).
• Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis). Participants with irritable bowel syndrome can be included in the clinical investigation.
• Participant has undergone major anorectal or bowel surgery or has ongoing anorectal or bowel conditions where primary surgery is considered the best, e.g., congenital anorectal malformation, bowel resection surgery, unrepaired rectovaginal fistula, chronic 4th degree anal sphincter laceration, full thickness rectal/anal prolapse. If it can be excluded that the participant's symptoms are related to any of the above surgeries/conditions, they can be included in the clinical investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Electrical stimulation (Time Limited stimulation) to the dorsal genital nerve.	Device: Time Limited stimulation; 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.; Other Names: UCon-Patch
Sham Comparator: Sham group; Sham stimulation to the dorsal genital nerve.	Device: Sham stimulation; 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.; Other Names: UCon-Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Incidence of serious adverse device effects (SADEs).	Number of SADEs.	At 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of treatment change [performance] of Urgency Urinary Incontinence.	Percentage of participants using UCon-Patch, compared to participants using UCon-Sham, demonstrating at least a 50% reduction in Urgency Urinary Incontinence (UUI).	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.	The ICIQ-OABqol score of participants using UCon-Patch, compared to participants using UCon-Sham (scores can range from 0 to 100, with lower values indicating higher QoL).	Change from baseline at 6 weeks.
Faecal Urgency (FU) episodes.	Mean reduction in number of Faecal Urgency (FU) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.	Change from baseline at 6 weeks.
Faecal Incontinence (FI) episodes.	Mean reduction in number of Faecal Incontinence (FI) episodes of participants using UCon-Patch, compared to participants using UCon-Sham.	Change from baseline at 6 weeks.
Incidence and severity of adverse events (AEs).	Number of AEs.	At 12 weeks.
Self-reported quality of life measures as assessed by the Rockwood Fecal Incontinence Quality of Life Scale (FIQL) questionnaire.	The FIQL score of participants using UCon-Patch, compared to participants using UCon-Sham (the scale consists of 4 scales, with each scale ranging from 1-5, with 1 indicating a lower functional QoL).	Change from baseline at 6 weeks.

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Urinary Incontinence; Urge incontinence; Neurostimulation; Fecal Incontinence; Dorsal Genital Nerve
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Urinary Incontinence; Enuresis; Nocturnal Enuresis; Fecal Incontinence; Urinary Incontinence, Urge; Nocturia
• Other Study ID Numbers: DK_PIVO_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No