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

NCT05368246 | Completed

• 1 other identifier: DK_FEAS_01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  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.

  Change from baseline QoL at 4 and 12 weeks.

Study Arms (1)

Interventional arm

EXPERIMENTAL

Electrical stimulation to the dorsal genital nerve.

Device: UCon

Interventions

UCon DEVICE

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InnoCon Medical: lead
• Aarhus University Hospital: collaborator
• Herlev Hospital: collaborator
• Odense University Hospital: collaborator

Study Sites (3)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Herlev Hospital

Herlev, Region Sjælland, 2730, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Grau LS, Christensen P, Qvist N, Klarskov N, Rijkhoff N, Duelund-Jakobsen J. Dorsal Genital Nerve Stimulation in Patients With Fecal Incontinence and Fecal Urgency: A Feasibility Study With the Novel UCon Neurostimulator. Neurogastroenterol Motil. 2025 Dec 20:e70225. doi: 10.1111/nmo.70225. Online ahead of print.

  PMID: 41420462 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Fecal Incontinence; Urinary Incontinence, Urge; Nocturia; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Peter Christensen

  Palle Juul Jensens Boulevard 99 DK-8200 Aarhus N

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 10, 2022
• Study Start: February 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)