Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)

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/daywithout 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 inSt. 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 followinstructions during the course of the investigation, including using the device athome.

Exclusion Criteria:

1. Participant is medically unstable (acute illness or complication of a chroniccondition, 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 activemedical devices (any medical device that uses electrical energy or other sources ofpower to make it function).

4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with anegative pregnancy test). Women of childbearing potential must maintain effectivecontraception during the clinical investigation.

5. Participant is enrolled or planning to enrol in another conflicting clinicalinvestigation or was enrolled in an investigational drug trial or medical deviceinvestigation within four weeks of enrolment.

6. Participant has neuropathy to a degree that is presumed to diminish the effect ofthe electrical stimulation.

7. Participant has a history of cancer in the pelvic region, are currently receivingcancer 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, contraceptivepatch, vaginal ring, and contraceptive injection.