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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Fecal Incontinence; Urge Incontinence; Urinary Incontinence, Urge; Nocturia; Urinary Frequency More Than Once at Night; Incontinence, Nighttime Urinary; Bowel Disorders Functional
• Intervention / Treatment: Device: UCon

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dianna Mærsk Knudsen; Phone Number: +45 40517712; Email: dmk@innoconmedical.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Aarhus University Hospital
  • Zealand
    • Herlev, Zealand, Denmark, 2730
      • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; Electrical stimulation to the dorsal genital nerve.	Device: UCon; The subjects self-administer electrical stimulation to the dorsal genital nerve (DGN) for 4 weeks using UCon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 4 and 12 weeks of stimulation (end of study).
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.	Change from baseline OAB/BD symptoms at 4 and 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 4 and 12 weeks of stimulation (end of study).
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.	Change from baseline QoL at 4 and 12 weeks.

Collaborators and Investigators

• Sponsor: InnoCon Medical
• Collaborators: Odense University Hospital; Aarhus University Hospital; Herlev Hospital
• Investigators: Principal Investigator: Peter Christensen, Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Urinary Incontinence; Urge incontinence; Nocturia; Neurostimulation; Fecal Incontinence; Dorsal Genital Nerve
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Rectal Diseases; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Urinary Incontinence; Intestinal Diseases; Enuresis; Fecal Incontinence; Urinary Incontinence, Urge; Nocturia; Nocturnal Enuresis
• Other Study ID Numbers: DK_FEAS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No