UCon Treatment of Overactive Bladder (OAB) in Males

InnoCon Medical

Status: Enrolling

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

Treatments: Device: Urge stimulation; Device: Time limited stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05874375

NL_FEAS_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).

2. 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)).

3. Subject has an active infection in the genital area incl. skin infections and urinary tract infection.

4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.

5. Subject has used antimuscarinics or β3 agonists within 14 days weeks*.

6. 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).

7. 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.

8. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.

9. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.

10. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.

11. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A (Urge and Time limited)

Other group

Description:

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.

Treatment:

Device: Time limited stimulation

Device: Urge stimulation

Group B (Time limited and Urge)

Other group

Description:

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.

Treatment:

Device: Time limited stimulation

Device: Urge stimulation