Urgent Urinary IncontinenceTRANSFORMNCT04408352
RF Ablation of the Trigone for the Treatment of UUI
A study testing selective bladder denervation using RF energy in people with Urgent Urinary Incontinence, run by Hologic, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urgent Urinary Incontinence
- What is being tested?
- selective bladder denervation using RF energy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Apr 2020to May 2030
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 32Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Center for Pelvic Health
Franklin, Tennessee, 37067
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Alleghany Health Network
Pittsburgh, Pennsylvania, 15224
Virginia Urology
Richmond, Virginia, 23230
Regional Urology, LLC
Shreveport, Louisiana, 71106
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
About this study
Official title: Selective Bladder Denervation Using RF Energy for the Treatment of UUI
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.
Read the 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 includes treatment with the Hologic trigone RF ablation device, or a control arm who receive a sham procedure. With a 2:1 randomization, approximately 150 subjects will be treated with the Hologic trigone RF ablation device (treatment group) and 75 sham subjects treated with the sham procedure.
Subjects will be blinded to their randomized treatment; however, due to the nature of the procedure, the treating investigator cannot be blinded to individual randomization assignments.
Subjects who are randomized to the treatment arm will be followed at 2 weeks, 1 month, 3, 6, and 12 months and every 6 months thereafter. Subjects randomized to the sham arm will be followed through the 6-month visit. Follow up of all other subjects (cross-over and treatment arm) will conclude when the last subject in randomized treatment arm reaches their 12-month visit, is withdrawn, or is determined lost to follow-up.
- Conditions
- Urgent Urinary Incontinence
- Being tested
- selective bladder denervation using RF energy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective bladder denervation using RF energyDevice
RF ablation of the trigone for the treatment of UUI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: selective bladder denervation using RF energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start27 Apr 2020
- Primary completionFeb 2030 (estimated)
- Study completionMay 2030 (estimated)
Why it stopped: for business planning purposes only, and is not related to any safety or performance issues identified during the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urgent Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408352
- Sponsor's protocol ID
- 1360-001
- Acronym
- TRANSFORM
- Status last verified
- Feb 2024
- First submitted
- 26 May 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Bladder Denervation Using RF Energy for the Treatment of UUI
- ClinicalTrials.gov ID
- NCT04408352
- Acronym / sponsor ID
- TRANSFORM / 1360-001
- Conditions
- Urgent Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: for business planning purposes only, and is not related to any safety or performance issues identified during the study
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 includes treatment with the Hologic trigone RF ablation device, or a control arm who receive a sham procedure. With a 2:1 randomization, approximately 150 subjects will be treated with the Hologic trigone RF ablation device (treatment group) and 75 sham subjects treated with the sham procedure.
Subjects will be blinded to their randomized treatment; however, due to the nature of the procedure, the treating investigator cannot be blinded to individual randomization assignments.
Subjects who are randomized to the treatment arm will be followed at 2 weeks, 1 month, 3, 6, and 12 months and every 6 months thereafter. Subjects randomized to the sham arm will be followed through the 6-month visit. Follow up of all other subjects (cross-over and treatment arm) will conclude when the last subject in randomized treatment arm reaches their 12-month visit, is withdrawn, or is determined lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| RF Trigone Ablation Treatment Arm | Active comparator | Device: selective bladder denervation using RF energyA 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. |
| RF Trigone Ablation Sham Arm | Sham comparator | Device: selective bladder denervation using RF energyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective bladder denervation using RF energyRF ablation of the trigone for the treatment of UUI | Device | RF Trigone Ablation Sham Arm, RF Trigone Ablation Treatment Arm |
Primary outcome
Primary Efficacy Endpoint
Time frame: 6 months
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.
Primary Safety Endpoint
Time frame: 12 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective bladder denervation using RF energy in people with Urgent Urinary Incontinence, run by Hologic, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.