Visceral Adiposity IndexNCT03280654
Visceral Adiposity Index and Overactive Bladder
An observational study of Visceral Adiposity Index, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Visceral Adiposity Index
- What is being tested?
- overactive bladder
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Sep 2017
- How long will I take part?
- 30 Months
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female patients over 18 years aged with overactive bladder symptoms
Who may be able to join
- Female patients over 18 years aged with overactive bladder symptoms
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Visceral Adiposity Index
- Being tested
- overactive bladder
- Keywords
- Obesity, Overactive Bladder, Urinary incontinence, Visceral Adiposity Index, Waist Circumference
- Medical subject headings
- Obesity, Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overactive bladderOther
Association between groups and over active bladder symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: overactive bladder | |
| 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 Receives: Other: overactive bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral adiposity index
Group 1(lower visceral adiposity index score) has lower over active bladder questionnaire scores than group 2(higher visceral adiposity index score)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2015
- Primary completion1 Jul 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral Adiposity IndexStudies of the same condition, open and under way.
- 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280654
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Adiposity Index and Overactive Bladder: A Novel Predictive Risk Factor
- ClinicalTrials.gov ID
- NCT03280654
- Acronym / sponsor ID
- 1
- Conditions
- Visceral Adiposity Index
- Keywords
- Obesity, Overactive Bladder, Urinary incontinence, Visceral Adiposity Index, Waist Circumference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:VAI levels <7,55 | – | Other: overactive bladder7,55 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 |
| group 2:VAI levels >=7,55 | – | Other: overactive bladder7,55 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female patients over 18 years aged with overactive bladder symptoms
Key inclusion criteria (1 listed)
- Female patients over 18 years aged with overactive bladder symptoms
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| overactive bladderAssociation between groups and over active bladder symptoms | Other | Group 1:VAI levels <7,55, group 2:VAI levels >=7,55 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Adiposity Index, run by Recep Tayyip Erdogan University Training and Research 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 1 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: finished, as of the sponsor's last update on 12 Sep 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Visceral adiposity index (time frame: 1 day). It is what the study was designed to measure, not a finding.
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 12 Sep 2017.