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NCT05874375 | Recruiting | Urinary Incontinence

UCon Treatment of Overactive Bladder (OAB) in Males
Sponsor:

InnoCon Medical

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.

Condition or disease

Urinary Incontinence

Urge Incontinence

Nocturia

Urinary Frequency More Than Once at Night

Urinary Incontinence, Urge

Incontinence, Nighttime Urinary

Intervention/treatment

Urge stimulation

Time limited stimulation

Phase

Not Applicable

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 20 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
Actual Study Start Date : October 12, 2023
Estimated Primary Completion Date : October 12, 2024
Estimated Study Completion Date : October 12, 2024
Arm Intervention/treatment

Other: Group A (Urge and Time limited)

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

Other: Group B (Time limited and Urge)

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 particiant. 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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
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.
UCon Treatment of Overactive Bladder (OAB) in Males

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UCon Treatment of Overactive Bladder (OAB) in Males

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Locations

Recruiting

Netherlands,

Maastricht University Medical Center+

Maastricht, Netherlands,