Evaluating a new device for treating overactive bladder and bowel dysfunction

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

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

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: InnoCon Medical (industry)
• Drugs / interventions: radiation
• Locations: 3 sites (Aarhus and 2 other locations)
• Trial ID: NCT06754189 on ClinicalTrials.gov

What this trial studies

This clinical investigation assesses the safety and performance of the UCon Patch Electrode, a medical device designed to electrically stimulate the dorsal genital nerve to alleviate symptoms of overactive bladder and bowel dysfunction. The study involves 180 participants who will be randomized into treatment and sham groups over a 12-week period. Participants in the treatment group will receive actual stimulation, while the sham group will receive non-therapeutic stimulation for the first six weeks. After this period, the treatment group may add additional stimulation, while the sham group will switch to the treatment device. The study aims to evaluate the device's effectiveness and safety compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with overactive bladder or bowel dysfunction who can communicate and follow instructions in Danish.

Not a fit: Patients with genital anatomy unsuitable for electrode placement or those with active infections in the genital area may not benefit from this study.

Why it matters

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

How similar studies have performed: Previous studies have shown promise with similar neurostimulation approaches, indicating potential for success in this investigation.

Eligibility criteria

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.

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