urge to urinate resulting in involuntary urination urinary urgency incontinence (UUI)) Incontinence
Conditions
Interventions
Miniature wireless midfield powered implanted neurostimulation device for
urinary urgency incontinence (UUI).
Sponsors
Neuspera Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Is willing and able to understand and has voluntarily signed and dated the current approved informed consent. Is male or female 22 years of age or older. Has a Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2. 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. Is ambulatory and able to use toilet without assistance. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date. Has 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. 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 the screening baseline visit. Has cystoscopy testing completed within 6 months prior to the screening baseline visit date or is willing to have a test at the screening baseline visit. Has failed or was not a candidate for more conservative treatment (e.g, pelvic floor exercise, biofeedback, behavioral modification). Has failed, could not tolerate (stopped taking medication due to lack of effectiveness or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or ß3 adrenoceptor agonist medication. 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. 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). Baseline Bladder Diary Inclusion Criteria: Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period.
Exclusion criteria
Exclusion criteria: Has a hemoglobin A1c of >8% or has diabetes mellitus with glucosuria. Has diabetic neuropathy. 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. Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator. Has broken, blistered skin or compromised circulation in the area of the neurostimulator implant. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident. Has documented urinary retention within 6 months prior to the screening baseline visit date. Has clinically significant bladder outlet obstruction. Is currently undergoing or has previously undergone pelvic irradiation. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer. Has current grade 3 or 4 pelvic organ prolapse including cystocele, rectocele, enterocele, procidentia or vaginal vault prolapse. 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. 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. 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. Has received treatment of urinary symptoms with any botulinum neurotoxin type-A (BoNT-A) agent in the past 12 months; (e.g. obotulinumtoxinA, Botox,® abobotulinumtoxinA, Dysport® IncobotulinumtoxinA, Xeomin®). 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. Has active substance abuse, including alcohol. Has a known hypersensitivity or contraindication to procedural or post-procedural medications which cannot be adequately managed medically. Has a known hypersensitivity to Neuspera’s SNM System device components. Has previously failed SNM therapy. Has active implantable medical devices such as neurostimulators, drug pumps, pacemakers, or internal defibrillators since compatibility has not been assessed. 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 e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is defined as the percentage of all implanted subjects who experience an improvement in UUI symptoms of at least 50% or more (therapy responders). A therapy responder is defined as experiencing =50% reduction in the number of UUI episodes at 6 months post-implant, relative to the number of UUI episodes at baseline. Statistical evaluation will be based on a comparison of the percentage of responders to a performance goal of 50%.Calculation of the primary effectiveness endpoint will be based on the mITT analysis set.t Safety (Phase II): The primary safety endpoint is defined as the incidence of device-related SAEs through the 6-month post-implant visit. The analysis of the endpoint is the proportion of subjects experiencing a device-related SAE through the 6-month post-implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints will be included in a hierarchical analysis of study endpoints and may be intended for labeling claims (all at 6-month visit post-implant follow-up):Change from baseline in mean number of UUI episodesChange from baseline in ICIQ-OABqol scoreThe percentage of subjects who experience an improvement in ICIQ-OABqol of at least 10 pointsChange in urgent episodes per day from baseline. Calculated across all diary episodes with at least mild urgencyChange in average number of daily voids from subjects with at least 8 voids at baseline Change in fecal incontinence as measured by the Wexner Scale compared to baseline. Calculated in subjects with fecal incontinence.The type I error for the primary effectiveness endpoint and for this subset of secondary endpoints will be controlled via hierarchical testing. Performance goals for each hypothesis and other statistical details are provided in the Statistical Analysis Plan (SAP).LTFU Primary Safety Endpoint: The primary safety endpoint for the LTFU phase is defined as the incidence of device- and procedure-related AEs. The analysis of the endpoint is the proportion of subjects experiencing a device- and/or procedure-related AE at yearly intervals through the study duration.LTFU Primary Effectiveness Endpoint: The primary effectiveness endpoint for the LTFU phase is defined as the percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more (therapy responders) at yearly intervals through the study duration. A therapy responder is defined as experiencing =50% reduction in the number of UUI episodes, relative to the number of UUI episodes at baseline.The endpoints for the LTFU include the following, which will be evaluated according to Error! Reference source not found. through the study duration:EffectivenessThe percentage of subjects who experience an improvement in UUI episodes (therapy responders) of at least 50% or more (pr | — |
Countries
Belgium, Netherlands, United States
Contacts
Public ContactM. Vollmer
Neuspera Medical Inc.
Outcome results
None listed