NCT03280654

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

2.5 years

First QC Date

September 7, 2017

Last Update Submit

September 9, 2017

Conditions

Keywords

ObesityOveractive BladderUrinary incontinenceVisceral Adiposity IndexWaist Circumference

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 day

Study Arms (2)

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

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

Interventions

Association between groups and over active bladder symptoms

Group 1:VAI levels <7,55group 2:VAI levels >=7,55

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with overactive bladder symptoms
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female patients over 18 years aged with overactive bladder symptoms

You may qualify if:

  • Female patients over 18 years aged with overactive bladder symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityUrinary Bladder, OveractiveUrinary Incontinence

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsUrination Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Recepteutrh

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 12, 2017

Study Start

January 1, 2015

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share