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NCT04451382 · ClinicalTrials.gov registry record
PTNS vs Botox of Refractory OAB
A clinical trial, sponsored by Medstar Health Research Institute.
- Terminated
- Registry status
- 150
- Enrollment target
NCT04451382: Clinical Trial study, sponsored by Medstar Health Research Institute.
NCT04451382 is a clinical trial that was terminated before completion, run by Medstar Health Research Institute. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04451382 was terminated before completion, sponsored by Medstar Health Research Institute.
- TERMINATED
- Registry status
- 150 participants
- Enrollment target
Study Summary
This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection or percutaneous tibial nerve stimulation (PTNS) as their next treatment. OAB-dry refers to patients with OAB who do not have urge urinary incontinence; OAB-wet refers to patients with OAB and urge urinary incontinence. Eligible patients will be approached for study participation after they have decided to proceed with BTX or PTNS.
Primary Outcome
The Patient Global Impression of Improvement (PGI-I) is a single question that asks a patient to rate her urinary symptom response to treatment on a 7-point Likert scaleis a validated questionnaire for assessment of the impact of OAB on patient's lives.
Interventions
- BIOLOGICAL OnabotulinumtoxinA (BoNTA)
- PROCEDURE Percutaneous tibial nerve stimulation (PTNS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-12 |
Why NCT04451382 stopped before completion
NCT04451382 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which OnabotulinumtoxinA (BoNTA) is the first listed.
NCT04451382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04451382 about?
NCT04451382 is a clinical study titled "PTNS vs Botox of Refractory OAB". This is a prospective cohort study of women with overactive bladder OAB (dry or wet) who have failed 2 prior treatments, including behavioral modification, pelvic floor physical therapy, and/or OAB medication (anticholinergics or mirabegron), and have chosen either OnabotulinumtoxinA (BTX) injection...
What is the current status of trial NCT04451382?
This trial is currently terminated. The enrollment target is 150 participants. The study started on 2015-03. Estimated completion is 2018-12.
What interventions are being tested in trial NCT04451382?
The interventions under investigation include: OnabotulinumtoxinA (BoNTA) (BIOLOGICAL), Percutaneous tibial nerve stimulation (PTNS) (PROCEDURE).
Who is sponsoring clinical trial NCT04451382?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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