Clinical Study of Neuspera*s Implantable Sacral Nerve Stimulation (SNS) System in Patients with Symptoms of Urinary Urgency Incontinence (UUI)
- Conditions
- urge to urinate resulting in involuntary urinationurinary urgency incontinence (UUI))10004994
- Registration Number
- NL-OMON54773
- Lead Sponsor
- euspera Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1. Is willing and able to understand and has voluntarily signed and dated the
current approved informed consent.
2. Is male or female 22 years of age or older.
3. Has a Body Mass Index (BMI) between 18 and 40 kg/m^2.
4. Is a good surgical candidate and is capable of participating in all testing
and follow-up clinic visits associated with this clinical study and is capable
of independently using the system components as described in the Patient Manual.
5. Is ambulatory and able to use toilet without assistance.
6. Has a diagnosis of UUI for greater than or equal to 6 months prior to the
screening baseline visit date.
7. Has a typical residual bladder volume < 150 cc tested within 6 months prior
to the screening baseline visit date or is willing to have a test at screening
baseline visit.
8. Has urodynamic testing (uroflowmetry, cystometry, and pressure flow)
completed within 6 months prior to the screening baseline visit date or is
willing to have testing at screening baseline visit.
9. Has cystoscopy test completed within 6 months prior to the screening
baseline visit date or is willing to have a test at screening baseline visit.
10. Has failed or was not a candidate for more conservative treatment (e.g,.
pelvic floor exercise, biofeedback, behavioral modification).
11. Has failed, could not tolerate (stopped taking medication due to lack of
efficacy or intolerable side effects), or not a good candidate for (as
determined by treating physician) at least one (1) antimuscarinic or β3
adrenoceptor agonist medication.
12. Is willing and able to washout (at least five half-lives) from OAB
medications for a period determined appropriate based on type of OAB medication
prior to the baseline bladder diary and remain off OAB medications through the
12-month follow-up visit.
13. Has appropriate sacral anatomy as determined by sponsor*s and
investigator*s analysis of radiographic imaging. (The distance from the
surface of the skin in the prone and seated position to the bone edge of the S3
foramen must be within the capabilities of the system).
Bladder Diary Inclusion Criteria:
14. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and
minimum of 1 UUI episodes per 24-hour period.
1. Has a hemoglobin A1c of >8% or has diabetes mellitus with glucosuria
2. Has diabetic neuropathy.
3. Has interstitial cystitis or bladder pain syndrome as defined by either
American Urological Association (AUA) or European Association of Urology (EAU)
guidelines, chronic pelvic pain or recurrent symptomatic urinary tract
infections.
4. Has skin, orthopedic, neurological or hematological (bleeding disorder) or
anatomical limitations that could prevent successful placement of the
neurostimulator.
5. Has broken, blistered skin or compromised circulation in the area of the
neurostimulator implant.
6. Has neurogenic bladder dysfunction such as traumatic or atraumatic
myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular
accident.
7. Has documented urinary retention within 6 months prior to the screening
baseline visit date.
8. Has clinically significant bladder outlet obstruction.
9. Is currently undergoing or has previously undergone pelvic irradiation.
10. Is a subject with a mechanical obstruction such as benign prostatic
hypertrophy, urethral stricture or cancer.
11. Has current grade 3 or 4 pelvic organ prolapse including cystocele,
rectocele, , enterocele, procidentia or vaginal vault prolapse.
12. Has symptomatic urinary tract infection (UTI); the subject may be
considered for study enrollment if the subject is symptom-free after a full
course of treatment prior to beginning the baseline bladder diary. If an
asymptomatic bacteriuria is detected during the urinalysis performed at
screening, a subject may be enrolled without a waiting period relative to UTI
treatment.
13. Has primary stress incontinence or mixed incontinence where the stress
component predominates or has been treated surgically for stress urinary
incontinence within 6 months prior to the screening baseline visit date.
14. Has received tibial nerve stimulation (TNS) in the past 3 months for the
treatment of overactive bladder or unwilling to stay off TNS therapy for
12-month period following implant.
15. Has received treatment of urinary symptoms with any botulinum neurotoxin
type-A (BoNT-A) agent in the past 12 months; (e.g. obotulinumtoxinA, Botox,®
abobotulinumtoxin A , Dysport,® IncobotulinumtoxinA, Xeomin®)
16. Is a woman who is pregnant or planning to become pregnant during this
clinical study or is a woman of child-bearing potential who is not using a
medically-acceptable method of birth control. Women of child-bearing potential
must undergo a pregnancy test, with clear negative result.
17. Has active substance abuse, including alcohol.
18. Has a known hypersensitivity or contraindication to procedural or
post-procedural medications which cannot be adequately managed medically.
19. Has a known hypersensitivity to Neuspera*s SNS System device components.
20. Has previously failed SNS therapy
21. Has active implantable medical devices such as neurostimulators, drug
pumps, pacemakers, or internal defibrillator since compatibility has not been
assessed.
22. Has known needs for diathermy (shortwave, microwave, or therapeutic
ultrasound), and radiofrequency ablation, in the vicinity of the
neurostimulator since these procedures have not been evaluated.
23. Has a known need for therapeutic ultrasound in the area of the sacral nerve
neurostimulator a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy (Phase II):<br /><br>The primary efficacy endpoint is defined as the percentage of all implanted<br /><br>subjects who experience an improvement in UUI symptoms of at least 50% or more<br /><br>(therapy responders). A therapy responder is defined as experiencing >=50%<br /><br>reduction in the number of UUI episodes at 6 months post-implant, relative to<br /><br>the number of UUI episodes at baseline. Statistical evaluation will be based on<br /><br>a comparison of the percentage of responders to a performance goal of 50%.<br /><br>Calculation of the primary endpoint will be based on the mITT analysis set<br /><br><br /><br>Safety (Phase II):<br /><br>The primary safety endpoint is defined as the incidence of device-related SAEs<br /><br>through the 6-month post-implant visit. The analysis of the endpoint is the<br /><br>proportion of subjects experiencing a device-related SAE through the 6-month<br /><br>post-implant.</p><br>
- Secondary Outcome Measures
Name Time Method