Status:
SUSPENDED
RF Ablation of the Trigone for the Treatment of UUI
Lead Sponsor:
Hologic, Inc.
Collaborating Sponsors:
NAMSA
Conditions:
Urgent Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The primary objective of this pivotal study is to collect data on the safety and effectiveness of the Hologic trigone RF ablation device to reduce urgency urinary incontinence. Up to 325 subjects will...
Detailed Description
Up to 325 subjects who meet all inclusion and none of the exclusion criteria will be enrolled and up to 225 subjects will be randomized. Subjects will be randomized to either an active arm that includ...
Eligibility Criteria
Inclusion
- 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.
- Subject is ≥18 years of age
- Subject has a history of idiopathic UUI for ≥ 6 months
- 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
- Ambulatory and able to use toilet without assistance
- Post-void residual (PVR) ≤ 150 ml
- Intolerant of, contraindicated for, or have failed drug therapy AND should not be on medications for their condition for at least 2 weeks prior
- 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
- 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)
- ≥ 4 episodes of urgency urinary incontinence (UUI) over 3-day Bladder Diary (an average of 1.33 UUI episodes/day)
Exclusion
- Planning on becoming pregnant during the 36-month study period
- 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
- Current bleeding disorder or coagulopathies
- Neurological disease affecting bladder function such as multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease
- Subject has uncontrolled diabetes (HbA1C \>8.5) documented in the last three months
- Subject is a chronic corticosteroid user defined as daily continuous use within the last 30 days
- Subject is critically ill or has a life expectancy \<3 years
- Investigator determines that subject is not a suitable candidate for participation in an investigational clinical research study
- Post-surgical onset of de novo OAB
- Current hydronephrosis or hydroureter
- Patients with uninvestigated microhematuria
- Impaired voiding dysfunction due to underactive bladder or bladder outflow obstruction
- Current participation in any other interventional study. Participation in observational studies is permitted
- Prior or current diagnosis of polyuria or has a screening 3-day bladder diary with 24-hour total volume of \> 3000 ml
- 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
- 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
- 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
- Anatomical conditions that, in the opinion of the investigator, would preclude the introduction and/or use of the device
- Any prolapse at or beyond the hymen
- Subject has been diagnosed (at any time) with bladder cancer, interstitial cystitis or chronic pelvic pain syndrome
- Ureteral dysfunction, stricture or reflux including vesicoureteral reflux or a history of surgical treatment for vesicoureteral reflux
- 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
- 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)
- Prior history of surgical mesh in the anterior vaginal compartment to treat pelvic organ prolapse
- History of complications with any transvaginal or mid-urethral implanted mesh
- 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
- Current use of OAB medications within the last 2 weeks
- OAB symptoms previously treated with a single injection of \>100 units of Onabotulinum Toxin A (Botox®)
- OAB symptoms previously treated with Sacral Neuromodulation (SNM) and/or PTNS
- Previous pelvic irradiation
- Complete or total incontinence (i.e. the continuous or total loss of urinary control)
- Any functional incontinence (incontinence caused by a physical or mental impairment that keeps a subject from reaching the bathroom in time to urinate)
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT04408352
Start Date
April 27 2020
End Date
May 1 2030
Last Update
February 28 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Cypress Medical Research Center, LLC
Wichita, Kansas, United States, 67226
2
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
3
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
4
Alleghany Health Network
Pittsburgh, Pennsylvania, United States, 15224