- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280654
Visceral Adiposity Index and Overactive Bladder
September 9, 2017 updated by: Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
Visceral Adiposity Index and Overactive Bladder: A Novel Predictive Risk Factor
In present study, we aimed to investigate the association between visceral adiposity index and overactive bladder symptoms in female patients aged over 18 years.Between January-2015 and July-2017, 151 female patient with overactive bladder symptoms were evaluated in Recep Tayyip Erdogan University Training and Research Hospital Urology Department.
Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels, and also urodynamic findings were recorded.
Visceral adiposity index was calculated according to gender-specific formula.
Participants were divided into two groups according to 7,55 cut-off level for visceral adiposity index levels.
Statistical significance were discussed between two groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Antropometric and laboratory features including serum lipid levels, AST, ALT, fasting glucose levels were recorded.
Urodynamic study was performed all of patients to evaluate bladder functions.
Over active bladder questionnaire-8 Turkish validated short form was filled out and recorded for each patients.
Detailed medical histories of all patients were obtained before the study.
Height, weight, and waist circumference (WC) were measured with the subjects in their underwear.
Body mass ındex (BMI) was computed by the formula as the ratio of weight to the square of height (kg/m2).
WC was measured on the line between the iliac crest and the lower costal margin parallel to the ground after subjects exhaled.
Inclusion criteria of study was female patients who have over active bladder symptomes with or without urinary incontinence.
Exclusion criterias of study were male gender, pregnancy, alcohol intake, bladder cancer history, previous incontinence surgery history, presence of neurological disease, urinary infection or bladder stone and pelvic radiotherapy history.
Study Type
Observational
Enrollment (Actual)
9
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
female patients over 18 years aged with overactive bladder symptoms
Description
Inclusion Criteria:
- Female patients over 18 years aged with overactive bladder symptoms
Exclusion Criteria:
- Male gender, pregnancy, alcohol intake, bladder cancer history, previous incontinence surgery history, presence of neurological disease, urinary infection or bladder stone and pelvic radiotherapy history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1:VAI levels <7,55
7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 Group 1 was defined as VAI levels <7,55
|
Association between groups and over active bladder symptoms
|
|
group 2:VAI levels >=7,55
7,55 value was calculated as cut-off level for VAI by ROC analyse and area under curve was calculated as 0,487 group 2 was defined as VAI levels >=7,55
|
Association between groups and over active bladder symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visceral adiposity index
Time Frame: 1 day
|
Group 1(lower visceral adiposity index score) has lower over active bladder questionnaire scores than group 2(higher visceral adiposity index score)
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2015
Primary Completion (ACTUAL)
July 1, 2017
Study Completion (ACTUAL)
September 1, 2017
Study Registration Dates
First Submitted
September 7, 2017
First Submitted That Met QC Criteria
September 9, 2017
First Posted (ACTUAL)
September 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 12, 2017
Last Update Submitted That Met QC Criteria
September 9, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 (Other Identifier: Mobile Health and Wellness Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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