NCT06091566 Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
| NCT ID | NCT06091566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | InnoCon Medical |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-01-12 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Peter Christensen, MD
PRINCIPAL INVESTIGATOR
Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
Frequently Asked Questions
Who can join the NCT06091566 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06091566 currently recruiting?
Yes, NCT06091566 is actively recruiting participants. Contact the research team at dmk@innoconmedical.dk for enrollment information.
Where is the NCT06091566 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herlev, Denmark, Odense, Denmark.
Who is sponsoring the NCT06091566 clinical trial?
NCT06091566 is sponsored by InnoCon Medical. The principal investigator is Peter Christensen, MD at Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N. The trial plans to enroll 20 participants.