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NCT05652036 · ClinicalTrials.gov registry record · Phase 4
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
A Phase 4 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 108
- Enrollment target
NCT05652036: Completed Phase 4 study, sponsored by The Methodist Hospital Research Institute.
NCT05652036 is a Phase 4 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 108 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05652036, a Phase 4 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 108 participants
- Enrollment target
Study Summary
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.
Primary Outcome
Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.
Interventions
- BIOLOGICAL Intradetrusor Botox Injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2023-05-15 |
| Phase | Phase 4 |
What the finished NCT05652036 record still lists
NCT05652036 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Intradetrusor Botox Injections is the first listed.
NCT05652036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05652036 about?
NCT05652036 is a clinical study titled "Procedural Discomfort Related to Number of Intradetrusor Botox Injections". Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based s...
What is the current status of trial NCT05652036?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2022-07-07. Estimated completion is 2023-05-15.
What interventions are being tested in trial NCT05652036?
The interventions under investigation include: Intradetrusor Botox Injections (BIOLOGICAL).
Who is sponsoring clinical trial NCT05652036?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05652036's enrollment target sits among peer trials
108 740th of 2000 higher than 1,256 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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