UCon Treatment of Overactive Bladder (OAB) in Males

NCT05874375 | Recruiting

• 1 other identifier: NL_FEAS_01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.

Conditions

Urinary Incontinence; Urge Incontinence; Nocturia; Urinary Frequency More Than Once at Night; Urinary Incontinence, Urge; Incontinence, Nighttime Urinary

Keywords

Urinary Incontinence; Urge incontinence; Neurostimulation; Dorsal Genital Nerve; Nocturia

Outcome Measures

Primary Outcomes (2)

• PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.

  Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.

  After 44 days (end of study)

• PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting

  Ratio of subjects with at least 50% change in their OAB symptoms from baseline. Participants shall complete a 3-day bladder diary to report their symptoms. The symptoms related to OAB: * 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.

  Change from baseline at 14 days, 30 days and 44 days (study end)

Secondary Outcomes (5)

• SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.

  After 44 days (end of study)

• SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.

  After 44 days (study end)

• SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.

  Change from baseline at 14 days and 44 days (end of study)

• SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.

  Change from baseline at 14 days and 44 days (end of study)

• SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.

  After 44 days (study end)

Study Arms (2)

Group A (Urge and Time limited)

OTHER

The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 60 seconds by the participant when he experience urgency (urge stimulation).The urge stimulation can be activated repeatedly during the day as the participant wears the device from morning to evening at home for 14 days. Following a stimulation wash-out period (14 days), the participants then stimulates with UCon for another 14 days using the time limited stimulation mode.

Device: Urge stimulation; Device: Time limited stimulation

Group B (Time limited and Urge)

OTHER

The participant self-administer electrical stimulation to the dorsal genital nerve (DGN) using UCon with a stimulation mode that is activated for 30 minutes once a day, at a time that is convenient for the participant. The participant uses the device at home for 14 days. Following a stimulation wash-out period (14 days), the participant then stimulates with UCon for another 14 days using the urge stimulation mode.

Device: Urge stimulation; Device: Time limited stimulation

Interventions

Urge stimulation DEVICE

Participants will receive stimulation for 60 seconds, when they feel an urgency.

Also known as: DGN stimulation, Neurostimulation

Group A (Urge and Time limited); Group B (Time limited and Urge)

Time limited stimulation DEVICE

Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.

Also known as: DGN stimulation, Neurostimulation

Group A (Urge and Time limited); Group B (Time limited and Urge)

Eligibility Criteria

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

You may qualify if:

• Subject is ≥ 18 years of age.
• Subject is male.
• Subject is diagnosed with OAB
• Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.

You may not qualify if:

• Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).
• Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).
• Subject has an active infection in the genital area incl. skin infections and urinary tract infection.
• Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.
• Subject has used antimuscarinics or β3 agonists within 14 days weeks\*.
• 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 enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation 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 alcohol, cannabis, opioids, or other intoxicating drugs.
• Subject does not speak and understand Dutch.
• If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.

Sponsors & Collaborators

• InnoCon Medical: lead

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Urinary 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; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• John Heesakkers, MD

  Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dianna Mærsk Knudsen

CONTACT

40517712; dmk@innoconmedical.dk

Study Design

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

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 24, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

NL (1)