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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: Clinical Trial Phase 3 study, sponsored by University of California, Irvine.

NCT02078895 is a Phase 3 study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Lower urinary tract symptoms (frequency, urgency, nocturia, dysuria) - Ureteral Stent Symptom Questionnaire (USSQ). The USSQ has different sections that pertain to different domains of a patient's life. Therefore, a total score from each section will be measured individually as described by Joshi et al (15). The different domains of the USSQ include urinary symptoms, body pain, general health, work performance, sexual matters. The total scores from each of these sections will be compared individ

Interventions

  • DRUG Botox

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-02
Est. Completion 2017-02
Phase Phase 3
University of California, Irvine

368 total trials

Why NCT02078895 stopped before completion

NCT02078895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Botox is the first listed.

NCT02078895 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02078895's enrollment target sits among peer trials

15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02078895, the US trial registry maintained by the National Library of Medicine. NCT02078895 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.