Phase 4
N=42
Validation of a Real-time Urodynamic Measure of Urinary Urgency
Overactive Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00909428 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in Maximal Cystometric Capacity (mL) — 95; 473.50 milliliters (mL) — p=.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Solifenacin Succinate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Loyola University
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maximal Cystometric Capacity (mL) |
95; 473.50 | .005 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Have symptoms of urge or mixed incontinence (urge predominant) and desire treatment with anticholinergic medication.
- Demonstrated detrusor overactivity with or without incontinence during urodynamic testing.
- Are able to consent and fill out study documents, complete repeated urodynamic testing, and follow-up in 4 weeks.
Exclusion Criteria
- Have been treated with any anticholinergic medication in the previous month.
- Have an elevated post -void residual volume as determined during their routine clinical care.
- Have had a urinary tract infection in the last month, as determined by history.
- Have untreated narrow angle glaucoma, by patient history.
- Have a known allergy or intolerance to solifenacin, as determined by patient history.
Data sourced from ClinicalTrials.gov (NCT00909428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.