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

NCT ID: NCT05368246

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-01-15

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.

Conditions

Urinary Incontinence; Fecal Incontinence; Urge Incontinence; Nocturia; Urinary Frequency More Than Once at Night; Bowel Disorders Functional; Urinary Incontinence, Urge; Incontinence, Nighttime Urinary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional arm

Electrical stimulation to the dorsal genital nerve.

Group Type: EXPERIMENTAL

UCon

Intervention Type: DEVICE

The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

Interventions

UCon

The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Herlev Hospital

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

InnoCon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Christensen

Role: PRINCIPAL_INVESTIGATOR

Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

Locations

Aarhus University Hospital

Aarhus, Aarhus N, Denmark

Herlev Hospital

Herlev, Region Sjælland, Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

Other Identifiers

DK_FEAS_01

Identifier Type: -

Identifier Source: org_study_id