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Validation of a Real-time Urodynamic Measure of Urinary Urgency

Primary Purpose

Overactive Bladder Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solifenacin Succinate
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring Bladder, Urinary Urgency, Solifenacin, Vesicare(R)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Solifenacin Succinate

Arm Description

The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.

Outcomes

Primary Outcome Measures

Change in Maximal Cystometric Capacity (mL)
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.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2009
Last Updated
April 18, 2017
Sponsor
Loyola University
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00909428
Brief Title
Validation of a Real-time Urodynamic Measure of Urinary Urgency
Official Title
Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University
Collaborators
Astellas Pharma Inc

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
Bladder, Urinary Urgency, Solifenacin, Vesicare(R)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin Succinate
Arm Type
Experimental
Arm Description
The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days.
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Other Intervention Name(s)
Vesicare(R)
Intervention Description
Participants take 10mg daily solifenacin succinate for 30 days
Primary Outcome Measure Information:
Title
Change in Maximal Cystometric Capacity (mL)
Description
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.
Time Frame
30 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary P FitzGerald, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available
Citations:
PubMed Identifier
16086677
Citation
Craggs MD. Objective measurement of bladder sensation: use of a new patient-activated device and response to neuromodulation. BJU Int. 2005 Sep;96 Suppl 1:29-36. doi: 10.1111/j.1464-410X.2005.05649.x.
Results Reference
background
PubMed Identifier
12478595
Citation
Oliver S, Fowler C, Mundy A, Craggs M. Measuring the sensations of urge and bladder filling during cystometry in urge incontinence and the effects of neuromodulation. Neurourol Urodyn. 2003;22(1):7-16. doi: 10.1002/nau.10082.
Results Reference
background
PubMed Identifier
12559262
Citation
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
Results Reference
background
PubMed Identifier
11744914
Citation
Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
Results Reference
background
PubMed Identifier
2514773
Citation
Herzog AR, Diokno AC, Fultz NH. Urinary incontinence: medical and psychosocial aspects. Annu Rev Gerontol Geriatr. 1989;9:74-119. doi: 10.1007/978-3-662-40455-3_3.
Results Reference
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Validation of a Real-time Urodynamic Measure of Urinary Urgency

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