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Tests treatment safety and results for Urinary Incontinence
Official title Safety and Performance of UCon Patch Electrode
ClinicalTrials.gov ID: NCT06754189
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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 has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or...
- Participant is pregnant, nursing, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12...
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- Participant has previously participated in a clinical investigation with UCon.
- Participant has failed (lack of how well it works) 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...
- 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...
- 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...
- 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 how well it works) 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Herlev, Denmark
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Herlev, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.