The purpose of the INTIBIA pivotal study is to demonstrate the safety and effectiveness of the INTIBIA System in the intended population through 24 months of follow-up. Data at 12-months will be used to support regulatory approval.The objective of…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The co-primary efficacy endpoints are defined as:
1. The proportion of ITNS-ON subjects achieving >= 50% reduction in urgency
urinary incontinence episodes relative to baseline versus a performance
threshold (PT) of 50% at 12 months. The endpoint will be considered met if the
ITNS-ON treatment group is statistically superior to the PT.
2. The proportion of subjects achieving a >= 50% reduction in urgency urinary
incontinence episodes relative to baseline at 3- months. The endpoint will be
considered met if the ITNS-ON treatment group is 1statistically superior by a
margin of 10% to the ITNS-SHAM treatment group .
Secondary outcome
Secondary Efficacy Endpoints will be tested for superiority of the ITNS-ON
group as compared to ITNS-SHAM group in the following order:
• The change in mean urgency score relative to baseline at 3- months.
• The change in mean number of daily voids relative to baseline at 3-months.
Background summary
Overactive Bladder (OAB) is a condition characterized by symptoms such as
urgency urinary incontinence, frequency, urgency, and nocturia. It is not a
disease but a collection of symptoms. The prevalence and severity of OAB
increase with age, affecting both men and women. Urgency urinary incontinence
is reported to be more common in women and is often the most bothersome symptom.
OAB has a negative impact on psychosocial functioning and quality of life. It
can affect daily activities, social interactions, and employment. It also
impacts sexual function, marital satisfaction, and can lead to increased
depression. OAB diagnosis involves ruling out other conditions such as
neurological diseases, diabetes, and pelvic organ prolapse through various
diagnostic tests.
The treatment of OAB is divided into four categories: behavioral modification,
pharmacological treatments, neuromodulation therapies, and invasive
interventions. Behavioral therapies include pelvic floor muscle strengthening,
journaling, and weight loss. Pharmacological treatments are the second-line
option but may have side effects that affect adherence. Neuromodulation
therapies, such as sacral nerve stimulation (SNS) and percutaneous tibial nerve
stimulation (PTNS), target the innervation system of the lower urinary tract.
SNS involves mild electrical impulses delivered to the sacral nerve roots via
an implanted neurostimulator, while PTNS stimulates the sacral nerve plexus
through the tibial nerve.
Studies have shown that both SNS and PTNS provide improvement in OAB symptoms,
with PTNS having fewer side effects and higher success rates compared to SNS.
The INTIBIA device is a programmable implantable tibial nerve stimulator (ITNS)
that is permanently implanted in the lower calf to deliver electrical pulses to
the tibial nerve. A clinical feasibility study of the INTIBIA device
demonstrated its safety and efficacy in treating OAB symptoms without any
serious adverse events or device deficiencies.
In conclusion, OAB is a collection of symptoms that can significantly impact an
individual's quality of life. Treatment options range from behavioral
modifications to invasive interventions, with neuromodulation therapies like
PTNS showing promising results. The INTIBIA device represents a programmable
ITNS with a miniaturized pulse generator and integrated electrode lead that
offers a potentially effective and convenient treatment option for OAB
patients.
Study objective
The purpose of the INTIBIA pivotal study is to demonstrate the safety and
effectiveness of the INTIBIA System in the intended population through 24
months of follow-up. Data at 12-months will be used to support regulatory
approval.
The objective of this study is to demonstrate the superiority of ITNS-ON to
ITNS-SHAM at 3-months and a performance threshold (PT) at 12-months in the
proportion of subjects achieving >=50% reduction in urgency urinary incontinence
(UUI) episodes.
Study design
The INTIBIA pivotal trial is a prospective, randomized, sham-controlled,
double-blind, multi-center study designed to evaluate the safety and efficacy
of an investigational ITNS device in subjects with UUI. Subjects will be
randomized to either ITNS-ON or ITNS-SHAM in a 2:1 ratio. Subjects randomized
to ITNS-SHAM will cross-over to ITNS-ON after the 3-month study visit and the
assessment of the 3-month efficacy endpoints.
Intervention
The intervention is the implantation of the INTIBIA device. The INTIBIA (TM)
ITNS is a single-use, programmable implantable tibial nerve stimulator (ITNS)
with a miniaturized pulse generator and an integrated electrode lead. The
INTIBIA (TM) ITNS is permanently implanted subcutaneously in the medial lower
calf, distal to the gastrocnemius muscle. The electrode lead provides
electrical pulses to the tibial nerve at a point 5 to 6 centimeters proximal to
the medial malleolus. The pulse generator autonomously provides neuromodulation
at a pre-set pulse pattern and frequency preset to match those of Percutaneous
Tibial Nerve Stimulation (PTNS), without requiring patient or physician
intervention post-operatively. The purpose of this intervention is to assess
the effectiveness of the ITNS device in managing symptoms of Overactive Bladder
(OAB) and improving the quality of life for the study subjects.
Study burden and risks
Burden:
Participation in the study may involve undergoing a surgical procedure for the
implantation of the INTIBIA ITNS device.
Subjects will need to adhere to pre-operative and post-operative instructions,
which may include discontinuation of blood thinners, antiseptic scrubbing,
wearing a compression sock, and avoiding certain activities for a period of
time.
The study requires subject follow-up comprising multiple visits over a minimum
of 24-month period, which may require time and effort from participants.
Screening tests such as catheterization and cystoscopy may be performed, which
can cause temporary discomfort or potential risks.
Participants may need to share personal information during the study, which
should be kept private and confidential.
Risks:
The implantation procedure carries risks typical of percutaneous implantation
procedures, such as infection, nerve/tissue/vessel damage, migration or
malfunction of the implanted device, and pain at the implant site.
There is a potential risk of the device being ineffective, resulting in the
continuation of UUI symptoms despite the intervention.
Screening tests like catheterization and cystoscopy carry their own risks,
including urinary tract infection, discomfort, urethral injury, and other
potential adverse effects.
Benefits:
The potential benefits of participation include the improvement of OAB
symptoms, such as urgency urinary incontinence episodes, urinary urgency
symptoms, frequency of voids per day, and nocturia episodes.
Participation contributes to the advancement of scientific and clinical
knowledge regarding the safety and effectiveness of the INTIBIA ITNS device.
Positive study results can potentially lead to improvements in the technical
capabilities and clinical practices for third-line OAB therapy.
There is the potential for future patients to benefit from the availability of
the INTIBIA ITNS device for routine use.
1601 West River Rd N 1601 West River Rd N
Minneapolis MN 55411
US
1601 West River Rd N 1601 West River Rd N
Minneapolis MN 55411
US
Listed location countries
Age
Inclusion criteria
1. Women or men 22-80 years of age
2. Symptoms of overactive bladder with urgency urinary incontinence (UUI)
demonstrated on a 72-hour voiding diary defined as a minimum of four (4)
leaking episodes associated with urgency, and at least one leaking episode each
24-hour period
3. Greater than or equal to 6-month history of UUI diagnosis
4. Failure of conservative or behavioral therapy (e.g., bladder diet, timed
voiding, bladder training, bladder control strategies, pelvic floor muscle
training, fluid management)
5. Willing to abstain from OAB medications for the duration of the study
6. Willing to maintain a stable dose of all other medications that affect
bladder function (e.g., tricyclic antidepressants) for at least four (4) weeks
prior to beginning the baseline voiding diary and baseline questionnaires
7. Ambulatory and able to use the toilet independently and without difficulty
8. Willing and capable of providing informed consent
9. Willing and able to complete all procedures and follow-up visits indicated
in the protocol
Exclusion criteria
1. Diagnosis of stress urinary incontinence or mixed urinary incontinence, as
confirmed by cough stress test and with a response of Yes to Q3 on the UDI-6
questionnaire
2. Current symptomatic urinary tract infection (UTI), urethritis, or more than
three (3) UTIs in past year
3. Have post-void residual urine volume >30% of total voided volume
4. Inadequate skin integrity or any evidence of an infection, edema or
inflammation in either lower leg
5. Evidence of anatomic abnormalities that could jeopardize the placement of
the device or pose a hazard to the subject
6. Prior treatment of urinary symptoms with nerve stimulation (e.g.,
percutaneous tibial nerve stimulation [PTNS] or sacral nerve stimulation [SNS])
7. History of chronic pain (e.g., chronic pelvic pain, fibromyalgia, Lyme
disease, chronic back pain)
8. An active implantable electronic device regardless of whether stimulation is
ON or OFF
9. Treatment of urinary symptoms with botulinum toxin therapy within twelve
(12) months
10.
Anyneurologicalconditionthatcouldinterferewithnormalbladderortibialnervefunction
,including stroke, epilepsy, multiple sclerosis, Parkinson*s disease,
peripheral neuropathy, fibromyalgia, or spinal cord injury (e.g., paraplegia)
11. Current urinary tract mechanical obstruction (e.g.,benign prostatic
enlargement or urethral stricture)
12. Other urinary tract dysfunction (e.g.,abnormal upper urinary tract
function, vesicoureteral reflux, bladder stone or tumor, urinary fistula)
13. Endstage renal failure,GFR<35, or dialysis
14. History of pelvic cancer within the past two years
15. Pelvic organ prolapse at or beyond the hymenal ring
16.
InterstitialcystitisorbladderpainsyndromeasdefinedbyeitherAmericanUrologicalAsso
ciation (AUA) or European Association of Urology (EAU) guidelines prior to
INTIBIA implant date
17. Diabetes with peripheral nerve compromise or uncontrolled diabetes
18. Pregnant as confirmed by urine or serum pregnancy test, plans to become
pregnant over the study period, is less than one-year post-partum, is
breast-feeding
19. Current active or a chronic systemic infection
20. Condition requiring magnetic resonance imaging(MRI) of lower leg
21. Condition requiring diathermy
22. Allergy to polyethylene terephthalate, silicone rubber, platinum, iridium,
or polyurethane
23. Allergy to local anesthetic or adhesives
24.
Deemedunsuitableforenrollmentbytheinvestigatorbasedonhistoryorphysicalexaminatio
n(e.g., bleeding disorders, current anticoagulant medications)
25. Enrolled in another investigational or interventional device or drug trial
over the study period
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 |
|---|---|
| ClinicalTrials.gov | NCT05250908 |
| CCMO | NL84762.100.23 |