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NCT02833402 · ClinicalTrials.gov registry record
Sacral Neuromodulation and the Microbiome
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 50
- Enrollment target
NCT02833402 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 50 participants.
The verdict
NCT02833402 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success. Recent studies suggest that the bacterial community that lives in the urinary tract plays a role in the development and continuation of urinary symptoms. It is proposed that the urinary microbiome may change in women before and after SNM implantation and this study aims to describe these changes. Investigators in this study also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples as well as questionnaire and medical data from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.
Interventions
- DEVICE InterStim Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-12 |
| Est. Completion | 2020-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02833402
The ClinicalTrials.gov registry entry for NCT02833402 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which InterStim Therapy is the first listed.
NCT02833402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02833402 about?
NCT02833402 is a clinical study titled "Sacral Neuromodulation and the Microbiome". Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sp...
What is the current status of trial NCT02833402?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2016-12. Estimated completion is 2020-09.
What interventions are being tested in trial NCT02833402?
The interventions under investigation include: InterStim Therapy (DEVICE).
Who is sponsoring clinical trial NCT02833402?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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