Treatment of Overactive Bladder and Bowel Dysfunction with UCon Bar Electrode

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the safety and performance of the UCon Bar Electrode, a medical device designed to treat symptoms of overactive bladder (OAB) and bowel dysfunction (BD) through electrical stimulation of the dorsal genital nerve. The study involves a cohort of 40 female patients who will undergo a screening period using a Patch Electrode followed by an intervention period with the Bar Electrode. Participants will use the device at home for either 4 or 12 weeks after a recovery period. The goal is to assess the device's effectiveness in reducing symptoms related to urinary and fecal incontinence.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Principal investigator: Peter Christensen, MD — Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
• Study coordinator: Dianna Mærsk Knudsen
• Email: dmk@innoconmedical.dk
• Phone: 40517712

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a new device for treating overactive bladder and bowel dysfunction

  This study is testing a new device that uses electrical stimulation to see if it can help people with overactive bladder and bowel issues feel better.

  Recruiting at 3 sites InnoCon Medical · Aarhus and 2 other locations · NCT06754189

• Treatment for Overactive Bladder in Men

  This study is testing a new device that uses electrical stimulation to see if it can help men with overactive bladder feel better.

  Recruiting InnoCon Medical · Maastricht · NCT05874375

• Beta-glucan cream added to standard skin care for IAD in hospitalized adults

  This study tests whether adding a 0.5% beta-glucan moisturizing cream to usual skin care helps adults with incontinence-associated dermatitis heal faster and feel better.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07524439

• Home biofeedback therapy for managing bowel and urinary issues

  This study is testing a new home therapy using a wireless device and a phone app to help people with bowel and urinary issues feel better and see if it's easier and cheaper than going to the doctor.

  Recruiting Augusta University · Augusta, Georgia · NCT05771597

• Comparing bladder therapies for older women with urinary incontinence

  This study is testing whether two different bladder treatments can help older women with urinary incontinence feel better compared to a placebo.

  Recruiting at 2 sites Phase 4 University of California, San Francisco · Palo Alto, California and 1 other locations · NCT05362292

• Comparing pain from different numbers of bladder injections of Botox

  This study is testing whether getting 5 or 20 Botox injections for overactive bladder causes more pain in women who haven't found relief from other treatments.

  Recruiting at 2 sites Phase 4 University of South Florida · Washington D.C., District of Columbia and 1 other locations · NCT04305743

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.