RF Ablation of the Trigone for the Treatment of UUI

Paused · Not applicable · Has a placebo group

Conditions studied: Urgent Urinary Incontinence

In brief

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 be enrolled with 225 randomized (2:1) and treated at up to 35 sites in the U.S. Additional sites in Canada, Australia, Europe, and other countries may also be considered. Sites outside of the U.S. cannot randomize more than 25% of subjects.

Key facts

Study ID: NCT04408352
Run by: Hologic, Inc.
People needed: 225
Starts: 2020-04-27
Expected to finish: 2030-05-01
Last updated by the study team: 2024-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Cypress Medical Research Center, LLC — Wichita, Kansas, United States
Regional Urology, LLC — Shreveport, Louisiana, United States
UPMC Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
Alleghany Health Network — Pittsburgh, Pennsylvania, United States
Center for Pelvic Health — Franklin, Tennessee, United States
Virginia Urology — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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