Primary Safety Objective: • To evaluate initial safety of UCon for treatment of OAB symptoms in a home setting.Secondary Safety Objective• To demonstrate that subjects using UCon do not experience an unacceptable amount of device- or procedure…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint
• Characterization of adverse events and anticipated adverse device effects
associated with the use of UCon.
Primary Performance Endpoint
• Ratio of subjects with at least 50% improvement of their OAB symptoms from
baseline.
Secondary outcome
Secondary Safety Endpoint
• Frequency and severity of all adverse events and anticipated adverse device
effects associated with the use of UCon.
Secondary Performance Endpoint
• Ratio of subjects with improvement in their OAB specific quality of life
measures from baseline.
• Ratio of subjects that accept UCon and DGN stimulation.
Background summary
Overactive bladder is a serious and common healthcare problem, which can have
devastating impact on patient*s quality of life, as it includes embarrassment
and severe social restrictions in many instances.
Treatment of overactive bladder consists mainly of medication, which are
associated with significant side effects resulting in a large group of patients
ending their treatment.
Within recent years neuromodulation has proven effective for treatment of OAB
by stimulating nerve fibers in sacral roots (SNS) placed near the spinal cord.
Despite the advantages and proven success of SNS, the initial costs of SNS are
still considerable and the current device is an invasive device, implanted in
the patient*s back.
The purpose of this study is to test a new medical device, UCon, which
electrically stimulates a nerve at the genitals (Dorsal Genital Nerve, DGN) for
the treatment of overactive bladder. UCon is designed with the stimulator being
placed outside the body, thus designed at significant lower costs than
implants. It also provides more possibilities to control and adjust treatment
protocols for optimizing the effect for each individual patient. Thereby, UCon
brings an affordable and minimally invasive treatment to the market helping a
large group of patients suffering and currently left with poor treatment
options, resulting in a poor quality of life.
The hypotheses are:
• UCon is safe for treatment of OAB in a home setting
• Subjects using UCon experience an improvement in their quality of life.
• Subjects using UCon do not experience an unacceptable number of device- or
procedure related adverse events.
• Subjects accept UCon and DGN stimulation.
Study objective
Primary Safety Objective:
• To evaluate initial safety of UCon for treatment of OAB symptoms in a home
setting.
Secondary Safety Objective
• To demonstrate that subjects using UCon do not experience an unacceptable
amount of device- or procedure related adverse events.
Primary Performance Objective
• To evaluate the performance of UCon for treatment of OAB symptoms in a home
setting.
Secondary Performance Objectives
• To evaluate whether subjects using UCon experience an improvement in their
quality of life.
• To evaluate the device and treatment acceptability of UCon.
Study design
This clinical investigation is a randomized, cross-over, single-site,
prospective, early feasibility study, which is used to evaluate the device with
respect to initial clinical safety and device performance in a small number of
subjects.
Intervention
The intervention of this clinical investigation is neuromodulation obtained by
electrical stimulation via UCon.
The subjects apply electrical stimulation 2 x 14 days. The cross-over design of
the study enables the subjects to try two types of electrical stimulation.
I.e., the subjects receive one type of stimulation for the first period of the
study, and then another type of stimulation during the second period of the
study.
The stimulation types are:
Time-limited stimulation: 30 minutes stimulation each day, when it is
convenient for the subject.
Urge stimulation: The subject activates stimulation when he experiences
urgency during wake hours. The stimulation lasts for 60 seconds and can be
stopped at any time.
Study burden and risks
During participation the subjects must:
- Visit the hospital 5-6 times
- Apply electrical stimulation for a minimum of 28 days
- Complete 3-days bladder diary 4 times
- Complete stimulation dairy 5 times
- Complete complications dairy 2 times
- Complete device and treatment satisfaction survey 2 times
- Complete Quality of Life Questionnaires 3 times
The risk associated with UCon treatment is very low. The primary method,
electrical stimulation, is well-known and has been applied in similar studies,
resulting in no long-lasting adverse events. If unanticipated adverse events
should occur, treatment can simply be discontinued. As with equivalent medical
devices, there is a risk of lack of effectiveness. However, much support for
the effectiveness of DGN stimulation to treat OAB is provided in the
literature. All risks identified in the risk analysis have been reduced as far
as possible through risk control measures.
The subjects might experience improvement of their OAB symptoms during the
stimulation periods and in a short period after. Due to this, the subjects will
not have a lasting therapeutic benefit after completion of the investigation.
It is, however, expected that the results from the investigation will
contribute to better treatment options for people suffering from OAB, which can
lead to:
• Improvement of OAB symptoms
• Improved ability to perform daily activities such as grocery shopping, going
to work, etc.
• Improved quality of life
Due to the few risks of UCon, serious harm to the subjects is very unlikely to
occur. However, if stimulation with UCon in a home-healthcare setting is a
viable solution for patients to treat their OAB symptoms, UCon will improve the
treatment options and thereby the quality of life for these patients. Based on
this, the disadvantages of conducting this investigation are minimal compared
to the benefits that can be obtained.
Lyngvej 1
Aalborg 9000
DK
Lyngvej 1
Aalborg 9000
DK
Listed location countries
Age
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
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 UTI.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81593.000.22 |