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

Primary Purpose

Urinary Incontinence, Fecal Incontinence, Urge Incontinence

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

UCon

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve, Nocturia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aarhus University HospitalRecruiting
Herlev HospitalRecruiting
Odense University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional arm

Arm Description

Electrical stimulation to the dorsal genital nerve.

Outcomes

Primary Outcome Measures

Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.

Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.

Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.

Urinary urgency is measured by number of urgency episodes/day. Urinary frequency is measured by number of voidings/day. Urgency urinary incontinence is measured by number of leaks preceded by urgency/day. Nocturia is measured by number of voidings/night. Faecal urgency is measured by number of urgency episodes/day. Frequent bowel movements are measured by number of voidings/day. Faecal incontinence (urge/passive) is measured by number of leaks/day.

Secondary Outcome Measures

Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.

Number of subjects experiencing adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period. Number and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.

Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.

For OAB the following is used to assess QoL: "International Consultation on Incontinence Questionnaire Overactive Bladder Module". It contains 4 questions and a higher total score means a worse outcome. For BD a combination of the following is used to assess QoL: "St. Marks incontinence score" and "Rockwood Fecal Incontinence Quality of Life Scale". St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome. The Rockwood Fecal Incontinence Quality of Life Scale contains 29 questions and a higher total score means a worse outcome.

Full Information

NCT ID

NCT05368246

First Posted

April 25, 2022

Last Updated

October 16, 2023

Sponsor

InnoCon Medical

Collaborators

Aarhus University Hospital, Herlev Hospital, Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05368246

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 28, 2023 (Actual)

Primary Completion Date

February 28, 2024 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InnoCon Medical

Collaborators

Aarhus University Hospital, Herlev Hospital, Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional arm

Arm Type

Experimental

Arm Description

Electrical stimulation to the dorsal genital nerve.

Intervention Type

Device

Intervention Name(s)

UCon

Intervention Description

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

Primary Outcome Measure Information:

Title

Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.

Description

Characterization of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon during the study period.

Time Frame

After 4 and 12 weeks of stimulation (end of study).

Title

Ratio of subjects with at least 50% improvement of their OAB/BD symptoms from baseline associated with the use of UCon.

Description

Time Frame

Change from baseline OAB/BD symptoms at 4 and 12 weeks.

Secondary Outcome Measure Information:

Title

Frequency and severity of all adverse events related to the risks and anticipated adverse device effects associated with the use of UCon.

Description

Time Frame

After 4 and 12 weeks of stimulation (end of study).

Title

Ratio of subjects with improvement in their OAB/BD specific quality-of-life measures from baseline.

Description

Time Frame

Change from baseline QoL at 4 and 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dianna Mærsk Knudsen

Phone

40517712

Ext

+45

dmk@innoconmedical.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Christensen

Organizational Affiliation

Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

State/Province

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Christensen

Phone

24661393

Ext

+ 45

petchris@rm.dk

First Name & Middle Initial & Last Name & Degree

Jakob Jakobsen

Phone

29 72 56 80

Ext

+ 45

jajakob@rm.dk

Facility Name

Herlev Hospital

City

Herlev

State/Province

Zealand

ZIP/Postal Code

2730

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Klarskov

Phone

38681406

Ext

+45

Niels.Klarskov@regionh.dk

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Quest, MD

Phone

29 69 46 25

Ext

+45

niels.qvist@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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