To demonstrate efficacy and safety of the treatment of UUI with BlueWind RENOVA iStim* System therapy.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy
• Proportion of responders at 6 months post system activation as demonstrated
by >=50% improvement in average number of urgency related
incontinence episodes, as measured by 7-day Patient Voiding Diary.
Overall study success criteria is defined as a lower 97.5%
confidence bound for a single binomial proportion of >50% patient success at 6
months.
Safety
• Incidence of adverse events from implantation to 12-months post-activation
Secondary outcome
• Proportion of subjects with >=10 points (MID) improvement in HRQL (based on
OAB-q) at 6 months post system activation
• Proportion of responders at 12 months post system activation as demonstrated
by >=50% improvement in either average number of urgency
related incontinence episodes or average number of severe/large urgency
related incontinence episodes, as measured by 7-day Patient Voiding Diary.
• Proportion of responders at 6 months post system activation as demonstrated
by >=50% improvement in the average number of moderate-severe urgency epsiodes
PPIUS degree 3,4 or <8 voids/day
Background summary
Non-neurogenic lower urinary tract dysfunction or Overactive bladder (OAB) is a
common urological chronic condition that significantly impairs the quality of
life of those affected, with considerable financial costs. OAB ranks among the
most prevalent and challenging problems in urology. Patients suffering from
that condition may complain of urgency and frequency, urge incontinence,
chronic pelvic pain or urinary retention. In most patients the etiology of
these complaints remains unclear. Earlier reports estimated that about one in
six adults in the United States and Europe have OAB .The prevalence of OAB
increases with age thus it is expected that OAB will become more common in the
future as the average age of people living in the developed world is
increasing.
A European study reports that the prevalence of OAB in Europe has been
estimated to be 15.6% and 17.4% for men and women respectively, with an overall
prevalence of 16.6%. The American Urological Association reports studies
showing rates as low as 7% to as high as 27% in men and rates as low as 9% to
43% in women. Urge incontinence was reported being higher in women. An
estimated 455 million worldwide experienced at least one OAB symptom in 2008,
with the prevalence expected to increase to 500 million in 2013 and 546 million
in 2018.
In addition to clinical consequences and economic costs, OAB is associated with
devastating losses in the quality of patient*s life. Patients with OAB often
reduce their social activities, become isolated and are predisposed to
depression. An array of pharmacologic, electromechanical, behavioral and
surgical interventions is used to treat OAB. However, for a significant
proportion of patients, response to treatment is poor and/or may be compromised
by troublesome or severe side effects. Therefore, other treatment modalities,
such as neuromodulation are needed to treat refractory OAB.
OAB is distinguished from other forms of urinary incontinence, including stress
incontinence and dysfunctions associated with neurogenic disorders and surgical
injury. The International Continence Society defines OAB as a condition
characterized by symptoms of urinary urgency with or without urge incontinence,
usually with urinary frequency (voiding eight or more times in a 24-hour
period) and nocturia (awakening two or more times a night to void). The key
symptom in OAB is urgency - defined as a sudden compelling desire to void,
which is difficult to defer. No precise cause for non-neurogenic OAB has been
identified, with physiologic abnormalities ruled out by diagnostic evaluation.
Although etiology remains elusive, a variety of risk factors are associated
with the development of OAB including older age, side effects of medications,
systemic chronic conditions, pregnancy/childbirth, neurological abnormalities,
endocrine irregularities, functional and behavioral factors and lower urinary
tract conditions.
Study objective
To demonstrate efficacy and safety of the treatment of UUI with BlueWind
RENOVA iStim* System therapy.
Study design
Prospective, Interventional, Multi-center, single arm, open label study
Intervention
Treatment will include a daily stimulation of a minimum of 30 minutes per day
and up to 120 minutes (a total of 2 hours per day), per physician discretion.
Subject therapy parameters will be adjusted according to the individual patient
sensations
Sensory and motor thresholds will be assessed and location of paresthesia
sensation will be assessed and recorded. Tailored patient therapy parameters
will be adjusted based upon patient tolerability, patient sensation and motor
threshold. Stimulation parameters will be modified for each patient in a
stepwise process, until a sensory response (tingling sensation in the ankle,
foot, toes and sometimes a radiation sensation in the leg and/or genital area)
OR a sensory response in combination with a motor response (flexion of the big
toe, fanning out of digits 2-5, extension of the foot) is elicited. The optimal
stimulation parameters selected will be comfortable and under the maximal
tolerability intensity level.
Stimulation parameters range is given below:
• Frequency of up to 30Hz
• Peak current of up to 14mA
• Pulse width of up to 790µsec
Study burden and risks
The potential risks related to this study are the known risks of surgical and
electrical stimulation. The sponsor and the investigators have determined that
this study is justified because of the potential benefit to patient*s symptoms
relief as a result of the BlueWind RENOVA system treatment effect.
Anticipated adverse events involved with the procedure are, but are not limited
to, pain at stimulator site, ankle discomfort, implant migration or
displacement, infection, nerve injury, skin irritation, skin erosion, sensation
of transient electric "shock"/ sudden radiating sensation / sporadic sensory
response, technical device problems, seroma, formation of thrombosis and
pulmonary embolism, allergic reaction, and potential temporary or permanent
mobility impairment.
Maskit 6
Herzliya 4614002
IL
Maskit 6
Herzliya 4614002
IL
Listed location countries
Age
Inclusion criteria
• 2 - Female aged 18 or greater (21 or greater in the US), with no plans to
become pregnant
during the trial; if of bearing potential, negative pregnancy test and
if sexually active, using
acceptable contraception.
• 4 - Diagnosis of UUI demonstrated on a 7-consecutive days voiding diary
defined as
a minimum of nine (9) leaking episodes associated with urgency with at
least one episode per
day for 5 days.
• 5 - More than or equal to 6 months history of UUI diagnosis
• 6 - Patient with inadequate response to any of the following conservative
treatments (i.e.
dietary restriction, fluid restriction, bladder training, behavioral
modification, pelvic muscle
training, biofeedback, etc.) and pharmacologic treatment.
Exclusion criteria
• 1 - Previous participation in another study with any investigational drug or
device
within the past 90 days
• 5 - Any significant medical condition that is likely to interfere with study
procedures,
device operation, or likely to confound evaluation of study endpoints
• 19 - More than minimal level of stress incontinence or mixed incontinence
with stress
component likely to confound study outcome, based on a 7-day voiding
diary or medical history,or when stress incontinence score in the MESA
incontinence questionnaire is higher than the urgency incontinence score
• 28 - Have a life expectancy of less than 1 year
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT03596671 |
| CCMO | NL66519.091.18 |