Safety and Performance of UCon Patch Electrode

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 andfollow instructions in Danish during the course of the investigation, includingoperation of the device at home.

Exclusion Criteria:

• Participant has genital anatomy that does not allow for proper electrode placementor 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 electrodeis placed.

• Participant is medically unstable (acute illness or complication of a chroniccondition, apart from the OAB or BD, that might affect the participant'sparticipation in the investigation).

• 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).

• Participant is pregnant, nursing, planning a pregnancy (to be confirmed with anegative pregnancy test) or has given birth within the previous 12 months. Women ofchildbearing potential must maintain effective contraception* during the clinicalinvestigation.

• Participant is enrolled or planning to enroll in another conflicting clinicalinvestigation 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 demyelinatingpolyneuropathy, 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 receivingcancer treatment, or has received radiation therapy in the pelvic region.

• Participant had surgery in the pelvic region within the previous 6 months. If it canbe excluded that the participant's symptoms are related to the surgery, they can beincluded 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, contraceptivepatch, vaginal ring, and contraceptive injection.

Exclusion Criteria specific for OAB:

• Participant is planning or has a scheduled surgery/diagnostic procedure (within theduration of their participation) for any condition, that would requirecatheterization. Or have a prolonged hospitalization that would affect the abilityto complete the stimulation.

• Participant (male) has symptoms of bladder outlet obstruction, e.g., caused bybenign prostatic hyperplasia or prostate cancer.

• Participant has polyuria or symptoms of polyuria.

• Participant has a current or reoccurring urinary tract infection (≥3 or more withinthe previous 12 months or ≥2 within the previous 6 months).

• Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixedincontinence 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 9months or has lasting benefit from BOTOX.

• Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2years.

• Participants who demonstrate detrusor overactivity on a urodynamic test can beincluded.

• Participant has used antimuscarinics or β3 agonists within 2 weeks.

• Participant has started oestrogen therapy within 3 months or are planning to stoptherapy when enrolled in the clinical investigation.

Exclusion Criteria specific for BD:

• Participant is planning or has a scheduled surgery/diagnostic procedure (within theduration of their participation), for any condition, that would influence theirbowel movements (e.g., injection of bulking agents, radiofrequency energy, orligation of haemorrhoids). Or have a prolonged hospitalization that would affect theability to complete the stimulation.

• Participant is currently being treated with antibiotics.

• Participant has a history of uncontrolled diarrhoea in the past 3 months (usual ormost common stool type over the preceding 3 months of 7 on the Bristol Stool FormScale).

• Participant has a history of severe constipation in the past 3 months (usual or mostcommon 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 diseaseand ulcerative colitis). Participants with irritable bowel syndrome can be includedin the clinical investigation.

• Participant has undergone major anorectal or bowel surgery or has ongoing anorectalor bowel conditions where primary surgery is considered the best, e.g., congenitalanorectal 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 theabove surgeries/conditions, they can be included in the clinical investigation.