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UCon Treatment of Overactive Bladder (OAB) in Males

Primary Purpose

Urinary Incontinence, Urge Incontinence, Nocturia

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Urge stimulation
Time limited stimulation
Sponsored by
InnoCon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Urge incontinence, Neurostimulation, Dorsal Genital Nerve, Nocturia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Maastricht University Medical Center+Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A (Urge and Time limited)

Group B (Time limited and Urge)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Number of subjects experiencing adverse events and anticipated adverse device effects. Subjects will report on any experience associated with the use of UCon.
SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.
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.
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
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.
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.
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.
SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.
Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.

Full Information

First Posted
May 1, 2023
Last Updated
October 16, 2023
Sponsor
InnoCon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05874375
Brief Title
UCon Treatment of Overactive Bladder (OAB) in Males
Official Title
Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
October 12, 2024 (Anticipated)
Study Completion Date
October 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InnoCon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Urge and Time limited)
Arm Type
Other
Arm 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.
Arm Title
Group B (Time limited and Urge)
Arm Type
Other
Arm 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 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.
Intervention Type
Device
Intervention Name(s)
Urge stimulation
Other Intervention Name(s)
DGN stimulation, Neurostimulation
Intervention Description
Participants will receive stimulation for 60 seconds, when they feel an urgency.
Intervention Type
Device
Intervention Name(s)
Time limited stimulation
Other Intervention Name(s)
DGN stimulation, Neurostimulation
Intervention Description
Participant will receive the stimulation as provided in time limited sessions (Range: 15 min - continuous), whenever it suits the participant during the day.
Primary Outcome Measure Information:
Title
PRIMARY SAFETY: To evaluate adverse events [initial safety] of UCon for treatment of OAB symptoms in a home setting.
Description
Characterization of adverse events and anticipated adverse device effects associated with the use of UCon during the investigational period.
Time Frame
After 44 days (end of study)
Title
PRIMARY PERFORMANCE: To evaluate the ratio of treatment change [performance] of OAB symptoms using UCon in a home setting
Description
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.
Time Frame
Change from baseline at 14 days, 30 days and 44 days (study end)
Secondary Outcome Measure Information:
Title
SECONDARY SAFETY: To identify the number of subjects experiencing adverse events associated with the use of UCon during the investigational period.
Description
Number of subjects experiencing adverse events and anticipated adverse device effects. Subjects will report on any experience associated with the use of UCon.
Time Frame
After 44 days (end of study)
Title
SECONDARY SAFETY: To evaluate the severity of adverse events associated with the use of UCon during the investigational period.
Description
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.
Time Frame
After 44 days (study end)
Title
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their quality of life.
Description
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.
Time Frame
Change from baseline at 14 days and 44 days (end of study)
Title
SECONDARY PERFORMANCE: To evaluate whether subjects using UCon experience a change in their treatment outcome (i.e. symptoms) after therapy.
Description
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.
Time Frame
Change from baseline at 14 days and 44 days (end of study)
Title
SECONDARY PERFORMANCE: To evaluate the device and treatment acceptability of UCon.
Description
Ratio of subjects that accept UCon and DGN stimulation as assessed by a satisfaction survey recorded after each stimulation period.
Time Frame
After 44 days (study end)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dianna Mærsk Knudsen
Phone
40517712
Ext
+45
Email
dmk@innoconmedical.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Heesakkers, MD
Organizational Affiliation
Maastricht UMC+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center+
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Heesakkers, MD
Phone
433877258
Ext
+31
Email
john.heesakkers@mumc.nl

12. IPD Sharing Statement

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UCon Treatment of Overactive Bladder (OAB) in Males

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