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NCT02078895 · ClinicalTrials.gov registry record · Phase 3
Randomization of Botox for Stent Pain and Irritative Voiding Symptoms
A Phase 3 study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT02078895 is a Phase 3 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 15 participants.
The verdict
NCT02078895, a Phase 3 study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study Summary
Botulinum toxin type A (Botox A) has shown great success in treating certain urologic conditions. A recent study has documented that Botox injected around the ureteral orifice (or place where the tube that connects the kidney to the bladder enters the bladder), during placement of a ureteral stent (small rubber tube that facilitate drainage of urine from the kidney to the bladder), resulted in a marked decline in the amount of stent pain experienced by patients. This finding was quite remarkable as stents are commonly used in many Urologic conditions, and these stents produce a remarkable degree of patient discomfort. Despite the great improvement in pain reduction, the irritative voiding symptoms \[frequent need to void, urgency, burning with urination (dysuria) or nighttime voiding (nocturia)\] were not ameliorated by the Botox injections in the ureteral orifice. However, it has already been well documented that in other clinical settings, administrations of Botox into the bladder muscle, has been shown to reduce these irritative symptoms. The objective of the study is to determine if pain and irritative lower urinary tract symptoms related to ureteral stent placement will improve after the injection of Botox around the ureteral orifice and in the bladder itself.
Interventions
- DRUG Botox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02078895
The ClinicalTrials.gov registry entry for NCT02078895 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 15 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 Botox is the first listed.
NCT02078895 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02078895 about?
NCT02078895 is a clinical study titled "Randomization of Botox for Stent Pain and Irritative Voiding Symptoms". Botulinum toxin type A (Botox A) has shown great success in treating certain urologic conditions. A recent study has documented that Botox injected around the ureteral orifice (or place where the tube that connects the kidney to the bladder enters the bladder), during placement of a ureteral stent (...
What is the current status of trial NCT02078895?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2014-02. Estimated completion is 2017-02.
What interventions are being tested in trial NCT02078895?
The interventions under investigation include: Botox (DRUG).
Who is sponsoring clinical trial NCT02078895?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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