Diabetes MellitusNCT00155610
The Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women
An observational study of Diabetes Mellitus, run by National Taiwan University Hospital.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- intravesical current perception test
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The diabetic women followed up in specialist clinics over one year at National Taiwan University Hospital (NTUH)
Who cannot join
- Concurrent neurological problems or other medical conditions that might interfere with voiding function
- Acute urinary tract infection (UTI)
- Previous pelvic surgery
- Vaginal prolapse
About this study
Official title: A Cross-Sectional Study of the Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- intravesical current perception test
- Keywords
- diabetic cystopathy, bladder, voiding dysfunction, current perception test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravesical current perception testDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study completionDec 2006
Why it stopped: No clinical significant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hong Jeng Yu, MD, Study chair, Unaffliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155610
- Sponsor's protocol ID
- 31MD01
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of the Relationship Between Voiding Dysfunction and Intravesical Sensory Threshold in Diabetes Women
- ClinicalTrials.gov ID
- NCT00155610
- Acronym / sponsor ID
- 31MD01
- Conditions
- Diabetes Mellitus
- Keywords
- diabetic cystopathy, bladder, voiding dysfunction, current perception test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No clinical significant
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study completion
- Dec 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The diabetic women followed up in specialist clinics over one year at National Taiwan University Hospital (NTUH)
Key exclusion criteria (4 listed)
- Concurrent neurological problems or other medical conditions that might interfere with voiding function
- Acute urinary tract infection (UTI)
- Previous pelvic surgery
- Vaginal prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravesical current perception test | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: No clinical significant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jeng Yu, MD study chair
Unaffliated
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No clinical significant). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.