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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

UCon-Bar

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

Eligibility Criteria

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

Inclusion Criteria: Participant is female Participant is ≥ 18 years of age. 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). 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: 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). Participant has an active infection in the genital area. 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). 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. 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. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 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.

Sites / Locations

Aarhus University Hospital
Herlev Hospital
Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electrical stimulation

Arm Description

Electrical stimulation to the dorsal genital nerve.

Outcomes

Primary Outcome Measures

PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.

1) Number and severity of adverse events during insertion of the UCon Bar Electrode: Excessive pain and excessive bleeding. 2) Number and severity of adverse events after insertion: Infection, pain, and bleeding. 3) Number of participants with successful insertion with no premature removal of the Bar Electrode.

PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms

Ratio of participants with at least 50% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.

Secondary Outcome Measures

SECONDARY SAFETY: Characterization, including frequency and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon-Bar Electrode.

1) Characterization of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.2) Number of participants experiencing adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.3) Number and severity of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.

SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms

Ratio of participants with at least 33% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.

SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience a change in their quality of life

Ratio of subjects with a change in their self-reported quality of life measures as assessed by specific QoL questionnaires related to OAB (ICIQ-OAB, an overall score with greater values indicates increased symptom severity) or BD (St. Marks incontinence score and Rockwood Fecal Incontinence Quality of Life Scale, an overall score with greater values indicates a worse symptom outcome.)

SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience an impression of treatment improvement

Ratio of participants with a self-reported improvement in their impression of treatment as assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. An improvement is defined as choosing one of the following: very much, better, much better, or a little better.

SECONDARY PERFORMANCE: ratio of participant that accept UCon and DGN stimulation [Device and treatment acceptability of UCon]

Ratio of participants that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation periods (with UCon Patch Electrode and UCon Bar Electrode) .

Secondary PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms during the screening period can be reproduced in the intervention period.

Ratio of participants with at least 50% reduction in symptoms using the UCon-Patch Electrode, that can be reproduced in 80% of the participants using the UCon Bar Electrode.

Full Information

NCT ID

NCT06091566

First Posted

October 16, 2023

Last Updated

October 23, 2023

Sponsor

InnoCon Medical

Collaborators

Aarhus University Hospital, Odense University Hospital, Herlev Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06091566

Brief Title

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

Official Title

Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InnoCon Medical

Collaborators

Aarhus University Hospital, Odense University Hospital, Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the 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. This clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.

Detailed Description

The overall purpose of the current clinical investigation is to evaluate the medical device with a UCon-Bar Electrode with respect to its initial safety and device performance in a cohort of 20 female patients with OAB/BD over a period of 12 weeks. The investigation consists of two periods: a screening period and an intervention period. During the screening period, the participants will be using UCon with a Patch Electrode and complete a 4 week stimulation period at home. The screening period will determine if participants fulfil the criteria to participate in the intervention period. During the intervention period, the UCon Bar Electrode will be inserted in the clitoral hood. After a recovery period (4-8 weeks), the participants will be using UCon with the Bar Electrode and complete wither a 4 week or a 12 week stimulation period at home.

6. Conditions and Keywords

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

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

Keywords

Urinary Incontinence, Fecal Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-group assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electrical stimulation

Arm Type

Experimental

Arm Description

Electrical stimulation to the dorsal genital nerve.

Intervention Type

Device

Intervention Name(s)

UCon-Bar

Other Intervention Name(s)

Electrical stimulation to the dorsal genital nerve (DGN stimulation)

Intervention Description

The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) for either 4 weeks or 12 weeks using UCon with the Bar electrode

Primary Outcome Measure Information:

Title

PRIMARY SAFETY: ratio of participants with successful insertion of the UCon Bar Electrode.

Description

1) Number and severity of adverse events during insertion of the UCon Bar Electrode: Excessive pain and excessive bleeding. 2) Number and severity of adverse events after insertion: Infection, pain, and bleeding. 3) Number of participants with successful insertion with no premature removal of the Bar Electrode.

Time Frame

After 4 weeks and 12 weeks

Title

PRIMARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms

Description

Ratio of participants with at least 50% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.

Time Frame

Change from baseline at 4 weeks and/or 12 weeks

Secondary Outcome Measure Information:

Title

SECONDARY SAFETY: Characterization, including frequency and severity of adverse events related to the risks and anticipated adverse device effects associated with the use of UCon-Bar Electrode.

Description

1) Characterization of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.2) Number of participants experiencing adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.3) Number and severity of adverse events and adverse device effects associated with the use of UCon-Bar during the investigational period.

Time Frame

After 4 weeks and 12 weeks

Title

SECONDARY PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms

Description

Ratio of participants with at least 33% reduction of their OAB/BD symptoms from baseline as assessed by subjective reporting in an electronic bladder or bowel diary.

Time Frame

Change from baseline at 4 weeks and/or 12 weeks

Title

SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience a change in their quality of life

Description

Ratio of subjects with a change in their self-reported quality of life measures as assessed by specific QoL questionnaires related to OAB (ICIQ-OAB, an overall score with greater values indicates increased symptom severity) or BD (St. Marks incontinence score and Rockwood Fecal Incontinence Quality of Life Scale, an overall score with greater values indicates a worse symptom outcome.)

Time Frame

Change from baseline at 4 weeks and/or 12 weeks

Title

SECONDARY PERFORMANCE: assess whether participants using UCon Bar Electrode experience an impression of treatment improvement

Description

Ratio of participants with a self-reported improvement in their impression of treatment as assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. An improvement is defined as choosing one of the following: very much, better, much better, or a little better.

Time Frame

After 4 week screening period, 4 weeks, and 12 weeks

Title

SECONDARY PERFORMANCE: ratio of participant that accept UCon and DGN stimulation [Device and treatment acceptability of UCon]

Description

Ratio of participants that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation periods (with UCon Patch Electrode and UCon Bar Electrode) .

Time Frame

After 4 week screening period, 4 weeks, and 12 weeks

Title

Secondary PERFORMANCE: ratio of treatment change [performance] of OAB/BD symptoms during the screening period can be reproduced in the intervention period.

Description

Ratio of participants with at least 50% reduction in symptoms using the UCon-Patch Electrode, that can be reproduced in 80% of the participants using the UCon Bar Electrode.

Time Frame

Change from screening period at 4 weeks and/or 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Participant is female Participant is ≥ 18 years of age. 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). 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: 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). Participant has an active infection in the genital area. 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). 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. 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. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs. 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.

Central Contact Person:

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

Dianna Mærsk Knudsen

Phone

40517712

Ext

+45

Email

dmk@innoconmedical.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Christensen, MD

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

ZIP/Postal Code

8200

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Christensen, MD

Phone

20375471

Ext

+45

Email

petchris@rm.dk

First Name & Middle Initial & Last Name & Degree

Jakob Jakobsen, MD

Facility Name

Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels Klarskov, MD

Phone

38 68 14 06

Ext

+45

Email

Niels.Klarskov@regionh.dk

Facility Name

Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mark Bremholm Ellebæk, MD

Phone

40 88 05 11

Ext

+45

Email

Mark.Ellebaek1@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD

No

Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial