| Eligibility |
Inclusion Criteria:
1. Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential
must have had a negative pregnancy test <7 days prior to procedure and must be using
medically accepted contraception or have a monogamous relationship with a partner who
has undergone sterilization.
2. Subject is =18 years of age
3. Subject has a history of idiopathic UUI for = 6 months
4. Subject is willing to provide Informed Consent, is geographically stable, has the
cognitive ability to complete the 3-day bladder diary and comply with the required
diary, follow up visits and testing schedule requirements
5. Ambulatory and able to use toilet without assistance
6. Post-void residual (PVR) = 150 ml
7. Intolerant of, contraindicated for, or have failed drug therapy AND should not be on
medications for their condition for at least 2 weeks prior
8. Predominance of urgency urinary incontinence in subjects with mixed incontinence (mix
of both stress and urgency incontinence) NOTE: Predominance is defined as having at
least 2/3rds or 67% of reported incontinence as urgency urinary incontinence on the
3-day bladder diary, and a higher percentage urgency urinary incontinence score as
compared to the SUI score on the MESA-UIQ
9. Subject has not previously received, or did receive = 100 units/intravesical treatment
of Onabotulinum Toxin A (Botox®) for OAB and self-reports receiving benefit from Botox
of normal durability (3-6 months), but discontinued or wishes to discontinue due to
side effects, financial constraints, or required treatment regimen (e.g., treatment
every 6 months)
10. = 4 episodes of urgency urinary incontinence (UUI) over 3-day Bladder Diary (an
average of 1.33 UUI episodes/day)
Exclusion Criteria:
1. Planning on becoming pregnant during the 36-month study period
2. Serum creatinine or BUN > twice the upper limit of normal within the last sixty days;
Impaired renal function as measured by glomerular filtration rate (GFR) = 65
3. Current bleeding disorder or coagulopathies
4. Neurological disease affecting bladder function such as multiple sclerosis, spinal
cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease
5. Subject has uncontrolled diabetes (HbA1C >8.5) documented in the last three months
6. Subject is a chronic corticosteroid user defined as daily continuous use within the
last 30 days
7. Subject is critically ill or has a life expectancy <3 years
8. Investigator determines that subject is not a suitable candidate for participation in
an investigational clinical research study
9. Post-surgical onset of de novo OAB
10. Current hydronephrosis or hydroureter
11. Patients with uninvestigated microhematuria
12. Impaired voiding dysfunction due to underactive bladder or bladder outflow obstruction
13. Current participation in any other interventional study. Participation in
observational studies is permitted
14. Prior or current diagnosis of polyuria or has a screening 3-day bladder diary with
24-hour total volume of > 3000 ml
15. Urinary tract infection (UTI) that is not resolved or has not been treated with
antibiotics for a minimum of 3 days at the time of procedure and has not been verified
by a negative urinalysis
16. Subject reports having, or has a documented history of = 2 urinary tract infections
(UTIs) in the last 6 months, or =3 UTIs in the last 12 months prior to enrollment
17. Documented, spontaneous, unprovoked urinary retention requiring any type of
catheterization within the last 6 months or retention in the past for which there was
no diagnosis or definitive treatment
18. Anatomical conditions that, in the opinion of the investigator, would preclude the
introduction and/or use of the device
19. Any prolapse at or beyond the hymen
20. Subject has been diagnosed (at any time) with bladder cancer, interstitial cystitis or
chronic pelvic pain syndrome
21. Ureteral dysfunction, stricture or reflux including vesicoureteral reflux or a history
of surgical treatment for vesicoureteral reflux
22. Any abnormality of the urinary tract including the bladder, ureters or kidneys such as
but not limited to: hydroureter, hydronephrosis, ureteric reflux, Hutch diverticulum,
ureterocele, duplex system, ectopic ureter, unilateral renal agenesis, ectopic kidney,
cross fused ectopia, or megaureter
23. Any invasive or surgical intervention involving the kidneys, bladder, urethra, rectum
or vaginal wall within the last 6 months (e.g., radiofrequency, implant, mid-urethral
sling)
24. Prior history of surgical mesh in the anterior vaginal compartment to treat pelvic
organ prolapse
25. History of complications with any transvaginal or mid-urethral implanted mesh
26. Prior abdominal, pelvic or vaginal surgery that may have modified the structure or
location of the bladder, ureters or urinary vasculature such as bladder
reconstruction, retroperitoneal dissection or cross-trigonal ureteral implantation,
urinary tract fistula repair
27. Current use of OAB medications within the last 2 weeks
28. OAB symptoms previously treated with a single injection of >100 units of Onabotulinum
Toxin A (Botox®)
29. OAB symptoms previously treated with Sacral Neuromodulation (SNM) and/or PTNS
30. Previous pelvic irradiation
31. Complete or total incontinence (i.e. the continuous or total loss of urinary control)
32. Any functional incontinence (incontinence caused by a physical or mental impairment
that keeps a subject from reaching the bathroom in time to urinate)
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