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NCT02550561 · ClinicalTrials.gov registry record · NA
Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT02550561 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 16 participants.
The verdict
NCT02550561, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM), involving a two stage surgical procedure and permanent device implantation. While the mechanism for decrease in IC/PBS symptoms is unknown, SNM is thought act through central and peripheral mechanisms related to afferent signaling, causing modification of pain and lower urinary tract sensation.¹ Percutaneous posterior tibial nerve stimulation (PTNS) is a method of peripheral neuromodulation targeting the same nerve roots as SNM, but with significantly fewer risks. The purpose of our research is to determine if PTNS is effective in the treatment of IC/PBS. The results of this study will suggest future directions and provide critical information to design studies to determine to what extent and in what situations PTNS may be effective. The investigators will enroll subjects with IC/PBS and urinary frequency/urgency to treatment with 12 weekly treatments of PTNS. The investigators will assess symptoms and lower urinary tract function before, during and after the treatments. At the completion of treatments, subjects will be asked to enroll in post-study follow up monitoring to understand the duration of symptom effect.
Interventions
- DEVICE Posterior Tibial Nerve Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-06 |
| Est. Completion | 2018-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02550561
The ClinicalTrials.gov registry entry for NCT02550561 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Posterior Tibial Nerve Stimulation is the first listed.
NCT02550561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02550561 about?
NCT02550561 is a clinical study titled "Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS". In 2014, the American Urological Association updated it management algorithm for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS). As the algorithm progresses, interventions become increasingly invasive and morbid. 4th line treatment is sacral neuromodulation (SNM), involving a two stage surg...
What is the current status of trial NCT02550561?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2015-06. Estimated completion is 2018-03.
What interventions are being tested in trial NCT02550561?
The interventions under investigation include: Posterior Tibial Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT02550561?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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