Clinical trial NCT05368246: Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
Official title: Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD) - An Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Fecal Incontinence
Urge Incontinence
Nocturia
Urinary Frequency More Than Once at Night
Bowel Disorders Functional
Urinary Incontinence, Urge
Incontinence, Nighttime Urinary
Keywords: Urinary Incontinence
Fecal Incontinence
Urge incontinence
Neurostimulation
Dorsal Genital Nerve
Nocturia
Lead sponsor: InnoCon Medical
Sponsor class: INDUSTRY
Collaborators: name: Aarhus University Hospital
name: Herlev Hospital
name: Odense University Hospital
First posted: 2022-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Subject is medically unstable.
2. Subject has an active infection in the genital area.
3. 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).
4. 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.
5. 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.
6. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.
7. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.
8. Subject has addictive behaviour defined as abuse of cannabis, opioids, or other intoxicating drugs.
9. Subject does not speak and understand Danish.

Primary outcomes:
measure: Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
timeFrame: After 4 and 12 weeks of stimulation (end of study).
measure: Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.
timeFrame: Change from baseline OAB/BD symptoms at 4 and 12 weeks.
Secondary outcomes:
measure: Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.
timeFrame: After 4 and 12 weeks of stimulation (end of study).
measure: Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.
timeFrame: Change from baseline QoL at 4 and 12 weeks.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Aarhus N
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Zealand
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N
name: Peter Christensen
role: PRINCIPAL_INVESTIGATOR
References: