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NCT Number: NCT05874375

UCon Treatment of Overactive Bladder (OAB) in Males

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.

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Key information

Conditions

Urinary Incontinence Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Nighttime Urinary Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nocturia Nocturnal Enuresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urge Incontinence Urinary Frequency More Than Once at Night Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center+

Maastricht, Netherlands

Location status: Recruiting

Location contact

John Heesakkers, MD

CONTACT

[email protected]

433877258 ext. +31

About this study

The purpose of the current investigation is to obtain information about the type of stimulation that Ucon provide (time limited vs. urge stimulation), would be the most effective and feasible for the treatment of non-neurogenic OAB symptoms in males.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Urge stimulation

Device

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

Other names: DGN stimulation, Neurostimulation

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.

Other names: DGN stimulation, Neurostimulation

Primary outcomes

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

    Time frame: After 44 days (end of study)

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

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

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

    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.

Secondary outcomes

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

    Time frame: After 44 days (end of study)

    Number of subjects experiencing adverse events and anticipated adverse device effects. Subjects will report on any experience associated with the use of UCon.

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

    Time frame: After 44 days (study end)

    Severity of adverse events and anticipated adverse device effects.The severity will be evaluated from the subjects' report on any experience associated with the use of UCon.

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

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

    Ratio of subjects with a change in their OAB quality of life measures as assessed by specific QoL questionnaires related to OAB condition (ICIQ-OAB, AOBq). An overall score with greater values indicates a worse symptom outcome.

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

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

    Ratio of subjects with a change in their treatment outcome (i.e. symptoms) assessed by the 7-point Patient Global Impression of Improvement (PGI-I) scale. Higher scores indicates a worse treatment outcome.

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

    Time frame: After 44 days (study end)

    Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.

Study contacts

Contact information is provided by the study sponsor or research team.

Dianna Mærsk Knudsen

CONTACT

[email protected]

40517712 ext. +45

Sponsors and collaborators

Lead sponsor

InnoCon Medical

Industry

Registry information

Official study title

Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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