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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
  Purpose

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 Intervention Phase
Overactive Bladder Syndrome Drug: Solifenacin Succinate Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Validation of a Real-time Urodynamic Measure of Urinary Urgency as a Measure of the Success of Drug Treatment

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 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.


Enrollment: 51
Actual Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909428

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Astellas Pharma Inc
Investigators
Principal Investigator: Mary P FitzGerald, MD Loyola University
  More Information

Publications:
Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00909428     History of Changes
Other Study ID Numbers: 109248
Study First Received: May 26, 2009
Results First Received: August 21, 2009
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available

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

Keywords provided by Loyola University:
Bladder
Urinary Urgency
Solifenacin
Vesicare(R)

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on June 23, 2017