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Validation of a Real-time Urodynamic Measure of Urinary Urgency

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00909428
First received: May 26, 2009
Last updated: April 18, 2017
Last verified: April 2017
May 26, 2009
April 18, 2017
January 2007
July 2008   (Final data collection date for primary outcome measure)
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.
Urgency as measured continuously during filling cystometry [ Time Frame: 1 month ]
Complete list of historical versions of study NCT00909428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Validation of a Real-time Urodynamic Measure of Urinary Urgency
Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

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.

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Overactive Bladder Syndrome
Drug: Solifenacin Succinate
Participants take 10mg daily solifenacin succinate for 30 days
Other Name: Vesicare(R)
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.
Intervention: Drug: Solifenacin Succinate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
February 2009
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00909428
109248
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
No
Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available
Loyola University
Loyola University
Astellas Pharma Inc
Principal Investigator: Mary P FitzGerald, MD Loyola University
Loyola University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP