Validation of a Real-time Urodynamic Measure of Urinary Urgency
|ClinicalTrials.gov Identifier: NCT00909428|
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Drug: Solifenacin Succinate||Phase 4|
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 `no urge at all` to 100 `maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.
Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment|
|Actual Study Start Date :||January 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||February 2009|
Experimental: Solifenacin Succinate
The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.
Drug: Solifenacin Succinate
Participants take 10mg daily solifenacin succinate for 30 days
Other Name: Vesicare(R)
- Change in Maximal Cystometric Capacity (mL) [ Time Frame: 30 Days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909428
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Mary P FitzGerald, MD||Loyola University|