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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    40
  • sponsor
    InnoCon Medical
Updated on 28 May 2022
electrical stimulation
overactive bladder
bladder diary

Summary

This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (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.

The study is conducted at multiple hospitals in Denmark (Aarhus University Hospital, Odense University Hospital and Herlev Hospital). It is estimated that 20 subjects with OAB and 20 subjects with BD will need to be enrolled at the investigational sites to account for screening attrition and dropouts. Screening and baseline measurements includes a 7-days bladder diary (OAB) / 14-days bowel diary (BD) and quality-of-life measures. Following the screening and baseline measurements, the subjects will be introduced and trained on how to set up and use UCon. For 1 month the subjects will use UCon at home and complete a daily bladder/bowel diary and a stimulation diary. After completion of the interventional period, subjects will fill out the quality-of-life measures once again.

Details
Condition Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night, Bowel Disorders Functional, Urinary Incontinence, Urge, Incontinence, Nighttime Urinary
Treatment UCon
Clinical Study IdentifierNCT05368246
SponsorInnoCon Medical
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is ≥ 18 years of age
Subject is diagnosed with OAB or BD
Subject is able to communicate, provide feedback, understand and follow instructions during the course of the study
Subject has signed an informed consent

Exclusion Criteria

Subject is medically unstable
Subject has an active infection in the genital area
Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function)
Subject is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test within 14 days prior to enrolment). Women of childbearing potential must maintain effective contraception during the study period judged by the investigator
Subject is enrolled or planning to enrol in another investigational study or was enrolled in an investigational drug or medical device trial within four weeks to enrolment
Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation
Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region
Subject has addictive behaviour defined as abuse of cannabis, opioids, or other intoxicating drugs
Subject does not speak and understand Danish
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