BridgeMD
Tests treatment safety and results for Urinary Incontinence
Official title Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
ClinicalTrials.gov ID: NCT06091566
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
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, women only
You may be able to join if
- Participant is female
- Participant is ≥ 18 years of age.
- Participant is diagnosed with OAB or BD. OAB: Urinary urgency usually with one or more of the following: i. Urinary urgency incontinence (≥1...
- Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the...
You likely can't join if
- 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 active infection in the genital area.
- 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 or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must...
- Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or...
- Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
See the full eligibility criteria
- Participant is female
- Participant is ≥ 18 years of age.
- 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...
- Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.
- 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).
- Participant has an active infection in the genital area.
- 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 or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.
- 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.
- Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
- Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.
- Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.
- 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.
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 female, 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.