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The Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women

This study has been terminated.
(No clinical significant)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00155610
First Posted: September 12, 2005
Last Update Posted: January 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The investigators will recruit a cross-sectional group of diabetic women in internist clinics. UDS will be applied for voiding function in each case. Intravesical electrical stimulation will be used to test CPT per 5 Hz, 250 Hz, 2000 Hz for the patients. The differences of intravesical CPT between diabetic women with and without voiding dysfunction will be determined.

Condition Intervention Phase
Diabetes Mellitus Device: intravesical current perception test Phase 1 Phase 2

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Cross-Sectional Study of the Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 120
Estimated Study Completion Date: December 2006
Detailed Description:

Diabetes is a common metabolic disease of multiorgan involvement. The American Diabetes Association reported that the prevalence of diagnosed and undiagnosed diabetes mellitus (DM) in the United States is currently 6% and rising. The increase is secondary to a rising incident in obesity, as well as a change in the criteria for the diagnosis of DM from a fasting blood glucose 140 mg/dl to 126 mg/dl. Besides impaired blood glucose regulation, many direct and indirect sequelae of DM can occur. Triopathy of diabetes including retinopathy, neuropathy, and nephropathy are familiar to every internist. Lower urinary tract dysfunction is one of the most common complications in this group of patients.

We look at the difference of intravesical sensation in diabetic women by current perception test; then, we can find the patient with diabetic cystopathy in early stage. We compare the groups of diabetic women with or without voiding dysfunction by urodynamic study. CPT test for intravesical sensation will be applied.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The diabetic women followed up in specialist clinics over one year at National Taiwan University Hospital (NTUH)

Exclusion Criteria:

  • Concurrent neurological problems or other medical conditions that might interfere with voiding function
  • Acute urinary tract infection (UTI)
  • Previous pelvic surgery
  • Vaginal prolapse
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00155610


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Hong Jeng Yu, MD Unaffliated
  More Information

ClinicalTrials.gov Identifier: NCT00155610     History of Changes
Other Study ID Numbers: 31MD01
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: January 30, 2008
Last Verified: September 2005

Keywords provided by National Taiwan University Hospital:
diabetic cystopathy
bladder
voiding dysfunction
current perception test

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases