Visceral Adiposity Index and Overactive Bladder: A Novel Predictive Risk Factor

Visceral Adiposity Index and Overactive Bladder



Sponsors


Source

Recep Tayyip Erdogan University Training and Research Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Completed

Start Date

2015-01-01

Completion Date

2017-09-01

Primary Completion Date

2017-07-01

Phase

N/A

Study Type

Observational [Patient Registry]

Primary Outcome

Measure

Time Frame

Visceral adiposity index
1 day

Number Of Groups

2

Enrollment

9

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

Association between groups and over active bladder symptoms

Arm Group Label

Group 1:VAI levels <7,55

group 2:VAI levels >=7,55



Eligibility

Study Pop

female patients over 18 years aged with overactive bladder symptoms

Sampling Method

Non-Probability Sample

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

Gender

Female

Gender Based

Yes

Gender Description

Female patients with overactive bladder symptoms

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Verification Date

2017-09-01

Lastchanged Date

2017-09-09

Firstreceived Date

2017-09-07

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Recep Tayyip Erdogan University Training and Research Hospital

Investigator Full Name

Mustafa Ozan HORSANALI

Investigator Title

Recepteutrh


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Group 1:VAI levels <7,55

Description

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


Arm Group Label

group 2:VAI levels >=7,55

Description

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



Firstreceived Results Date

N/A

Target Duration

30 Months

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Cross-Sectional



ClinicalTrials.gov processed this data on September 13, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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