RF Ablation of the Trigone for the Treatment of UUI
Public ClinicalTrials.gov record NCT04408352. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Selective Bladder Denervation Using RF Energy for the Treatment of UUI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04408352
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 27, 2020 (Actual)
- Primary completion
- Feb 2030 (Estimated)
- Completion
- May 2030 (Estimated)
- Last update posted
- Feb 28, 2024
2020 – 2030
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | — |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | — |
| UPMC Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Alleghany Health Network | Pittsburgh | Pennsylvania | 15224 | — |
| Center for Pelvic Health | Franklin | Tennessee | 37067 | — |
| Virginia Urology | Richmond | Virginia | 23230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04408352, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 28, 2024 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04408352 live on ClinicalTrials.gov.