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

Diabetes Mellitus Clinical Trial

Official title:

A Cross-Sectional Study of the Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00155610
• Other study ID #: 31MD01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: January 28, 2008
• Est. completion date: December 2006

Study information

• Verified date: September 2005
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• intravesical current perception test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital