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NCT06226220 · ClinicalTrials.gov registry record · NA
Percutaneous Nerve Evaluation Trial Time
A NA study of Overactive Bladder and Urge Incontinence, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 193
- Enrollment target
- 1
- Study location
NCT06226220 is a NA study of Overactive Bladder and Urge Incontinence that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 193 participants, roughly in line with the 207-participant average among 45 other Overactive Bladder trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT06226220, a NA study of Overactive Bladder and Urge Incontinence, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 193 participants
- Enrollment target
- 1
- Study location
Study Summary
Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation. Patients who experience a \> 50% improvement in UUI symptoms progress to permanent implantation. PNE offers significant advantages compared to a staged implantation including a single anesthetic and operating room trip. Historically, full implantation rates are only 40-50% following PNE versus 70-90% in women who undergo a staged approach. The lower rate of progression to full implantation after PNE may be attributed to lead migration. Newer data suggest up to 90% of PNE trials lead to full implantation. The investigators hypothesize that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.
Conditions Studied
Interventions
- PROCEDURE Sacral neuromodulation
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2023-12-10 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06226220
The ClinicalTrials.gov registry entry for NCT06226220 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 207-participant average among 45 other Overactive Bladder trials with a reported enrollment target. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Sacral neuromodulation is the first listed.
NCT06226220 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06226220 about?
NCT06226220 is a clinical study titled "Percutaneous Nerve Evaluation Trial Time". Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a pe...
What is the current status of trial NCT06226220?
This trial is currently recruiting. It is a NA study. The enrollment target is 193 participants. The study started on 2023-12-10. Estimated completion is 2026-12-31.
What conditions does trial NCT06226220 study?
This clinical trial studies the following conditions: Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome.
What interventions are being tested in trial NCT06226220?
The interventions under investigation include: Sacral neuromodulation (PROCEDURE).
Who is sponsoring clinical trial NCT06226220?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06226220 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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