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NCT00909428 · ClinicalTrials.gov registry record · Phase 4
Validation of a Real-time Urodynamic Measure of Urinary Urgency
A Phase 4 study, sponsored by Loyola University.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT00909428: Completed Phase 4 study, sponsored by Loyola University.
NCT00909428 is a Phase 4 study that has completed, run by Loyola University. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00909428, a Phase 4 study, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient. Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.
Primary Outcome
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug.
Interventions
- DRUG Solifenacin Succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-01 |
| Est. Completion | 2009-02 |
| Phase | Phase 4 |
What the finished NCT00909428 record still lists
NCT00909428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Solifenacin Succinate is the first listed.
NCT00909428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00909428 about?
NCT00909428 is a clinical study titled "Validation of a Real-time Urodynamic Measure of Urinary Urgency". Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constr...
What is the current status of trial NCT00909428?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2007-01. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00909428?
The interventions under investigation include: Solifenacin Succinate (DRUG).
Who is sponsoring clinical trial NCT00909428?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00909428's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 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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