RF Ablation of the Trigone for the Treatment of UUI

NCT04408352 | Suspended FDA Device

• 1 other identifier: 1360-001
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Urgent Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

  The proportion of UUI responders having a \> 50% decrease in UUI episodes from baseline to 6-month follow-up as documented on the 3-day bladder diary.

  6 months

• Primary Safety Endpoint

  All adverse events from randomized treatment through the close of the 12-month follow-up visit for subjects treated with the Hologic trigone RF ablation device.

  12 months

Study Arms (2)

RF Trigone Ablation Treatment Arm

ACTIVE COMPARATOR

A compatible standard cystoscopy lens (30°) will be inserted into the Hologic trigone RF Device. The bladder will be emptied of urine and saline infused into the bladder to allow adequate visualization and working space. Ablations at the trigone will be created using the Hologic trigone RF ablation device together with the compatible standard commercially available RF cannula and generator. It is expected that a subject would receive between 4-6 ablations to completely treat the appropriate area of the trigone. At the completion of the procedure, 200 ml of saline is instilled into the bladder to allow for assessment of voiding function prior to discharge.

Device: selective bladder denervation using RF energy

RF Trigone Ablation Sham Arm

SHAM COMPARATOR

The sham procedure will mimic the Hologic trigone RF ablation device procedure to maintain subject blinding and provide the most accurate assessment of control data while minimizing risk to the subject. The bladder will be emptied of urine and saline infused into the bladder to allow adequate visualization and working space. Suction will be applied to the bladder wall and the cannulas (needles) will be introduced into the bladder wall. Energy will not be delivered to the tissue when each sham "ablation" is started. In order to maintain blinding of the subject, the typical sounds that Hologic trigone RF ablation device makes during actual ablation/fulguration will be replicated. The simulated ablation procedure will be repeated as many times as necessary to cover the area of the trigone. 4 to 6 sham "ablations" would be required. At the completion of the procedure, 200ml of saline is instilled into the bladder to allow for assessment of voiding function prior to discharge.

Device: selective bladder denervation using RF energy

Interventions

selective bladder denervation using RF energy DEVICE

RF ablation of the trigone for the treatment of UUI

RF Trigone Ablation Sham Arm; RF Trigone Ablation Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will enroll adult (≥18 years of age), female subjects with urgency urinary incontinence (UUI) who are found to be intolerant of, contraindicated for, or have failed drug therapy and are not on medications for their condition.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hologic, Inc.: lead
• NAMSA: collaborator

Study Sites (6)

Cypress Medical Research Center, LLC

Wichita, Kansas, 67226, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Alleghany Health Network

Pittsburgh, Pennsylvania, 15224, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

Virginia Urology

Richmond, Virginia, 23230, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The device shall be assembled and maintained in a sterile environment outside the view of the subject during procedure preparation and treatment. The treating investigator, applicable nursing and site staff, and any representatives supporting the procedure should refrain from discussing the device or treatment assignment during the procedure and applicable follow-up visits. The sham procedure will mimic the Hologic trigone RF ablation device procedure to maintain subject blinding and provide the most accurate assessment of control data while minimizing risk to the subject. Energy will not be delivered to the tissue when each sham "ablation" is started.To be comparable to the Hologic trigone RF ablation device procedure, the simulated ablation procedure will need to be repeated as many times as necessary to cover the area of the trigone as is done in the treatment arm.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either the treatment with the Hologic trigone RF ablation device or a sham procedure. Randomization will occur in a 2:1 fashion (treatment: sham) meaning approximately 150 subjects will be treated with the Hologic trigone RF ablation device and 75 control subjects treated with the sham procedure. Randomization will be stratified by site.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: April 27, 2020
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)