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RF Ablation of the Trigone for the Treatment of UUI

NCT04408352 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2024-02-28

No results posted yet for this study

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

Interventions

DEVICE

selective bladder denervation using RF energy

RF ablation of the trigone for the treatment of UUI

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Hologic, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2030-02-28
Completion
2030-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408352 on ClinicalTrials.gov