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Visceral Adiposity Index and Overactive Bladder

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ClinicalTrials.gov Identifier: NCT03280654
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Visceral Adiposity Index Other: overactive bladder

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 9 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 30 Months
Official Title: Visceral Adiposity Index and Overactive Bladder: A Novel Predictive Risk Factor
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


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
Other: overactive bladder
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
Other: overactive bladder
Association between groups and over active bladder symptoms




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with overactive bladder symptoms
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
female patients over 18 years aged with overactive bladder symptoms
Criteria

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
Additional Information:

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Responsible Party: Mustafa Ozan HORSANALI, Recepteutrh, Recep Tayyip Erdogan University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03280654    
Other Study ID Numbers: 1
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital:
Obesity
Overactive Bladder
Urinary incontinence
Visceral Adiposity Index
Waist Circumference
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Obesity
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight