Urinary Cytokines in Patients With Overactive Bladder (OAB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Cleveland Clinic Florida.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Cleveland Clinic Florida
ClinicalTrials.gov Identifier:
NCT00868621
First received: March 23, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

Overactive bladder (OAB) is a widespread condition characterized by urgency, urge incontinence, nocturia and excessive urinary frequency, affecting millions of people worldwide.(1) In two epidemiological studies, OAB was found in about 17% of American and European populations.(2)(3). This accounts for an estimated 33 million patients suffering from OAB in the USA. The disorder constitutes a psychological stress that impacts the patient's social life.


Condition
Overactive Bladder
Urinary Tract Infection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Identification of Urinary Cytokines in Patients With Overactive Bladder (OAB)

Resource links provided by NLM:


Further study details as provided by Cleveland Clinic Florida:

Enrollment: 56
Study Start Date: March 2007
Estimated Study Completion Date: June 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Control
2
Overactive Bladder Patients
3
Urinary Tract Infection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Twenty healthy women (control), 20 women suffering from overactive bladder and other 20 women suffering from UTI will be selected for the study. Each control will be age matched within +/- 5 years to patients.

Criteria

Inclusion Criteria:

  • Group I (OAB patients)

    1. Women with OAB, ≥18 years and premenopausal non-menstruating, not on any anticholinergic for at least two weeks before enrollment in the study.
    2. Significant urgency,i.e., having moderate or severe urgency score.
    3. Having a score > 8 on the OAB-V8 questionnaire.
    4. Urinary frequency of more than 8/day, with urgency of urination, with or without urge incontinence.
    5. Negative screening urinalysis one month after documented UTI.
  • Group II (Control)

    1. Age-matched normal volunteers (≥18 years and premenopausal non-menstruating)
    2. No Urgency.
    3. OAB-8 score < 8.
    4. No UTI.
  • Group III (UTl)

    1. Age-matched
    2. ≥18 years and premenopausal non-menstruating women with culture proven UTI.

Exclusion Criteria:

  1. Treatable genitourinary conditions that could cause incontinence
  2. Hematuria
  3. Obstructive uropathy
  4. Patients diagnosed with vaginitis
  5. History of urothelial carcinoma
  6. Urinary tract infection (except group III)
  7. Pelvic radiation.
  8. Neurogenic bladder.
  9. Renal pathology.
  10. Stress urinary incontinence.
  11. Medications.
  12. Recent history of Botox injection in the bladder (Within the last year).
  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: NCT00868621

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Gamal Ghoniem, MD Cleveland Clinic Florida
  More Information

Publications:

Responsible Party: Astellas Pharma, US Inc, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT00868621     History of Changes
Other Study ID Numbers: IRB 8848
Study First Received: March 23, 2009
Last Updated: March 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Tract Infections
Urinary Bladder, Overactive
Infection
Urologic Diseases
Urinary Bladder Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014