Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder (NGF)

Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder.

Study Overview

Status

Unknown

Conditions

Detailed Description

Overactive bladder is a clinical syndrome characterized urgency, frequency and nocturia. Infection or other obvious causes must be excluded. The overactive bladder is loss of inhibition of the detrusor muscle during the filling or emptying of the bladder.

Specific receptors and neurotransmitters have role in development of overactive bladder. These includes adrenergic, cholinergic, non-adrenergic, non-cholinergic receptors and interstitial cells.

Nerve growth factor (NGF-R) receptors are between the detrusor muscle fibers and can cause afferent signals. Metabolic syndrome and obesity have been advocated to be risk factors for the development of overactive bladder. The investigators believe that our findings will shed light on treatment.

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Bakirkoy
      • Istanbul, Bakirkoy, Turkey, 34140
        • Recruiting
        • Bakirkoy Dr Sadi Konuk Training and Research Hospital
        • Contact:

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 to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with overactive bladder

Description

Inclusion Criteria:

  • women with urgency, nocturia and frequency
  • Abdominal obesity, defined as a waist circumference in men ≥88 cm
  • Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
  • Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL-C
  • Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
  • Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose

Exclusion Criteria:

  • Chronic obstructive pulmonary disease allergy
  • Psychiatric disorders
  • Urinary tract infection
  • Neurological diseases
  • Metabolic diseases
  • Pure stress or mixed urinary incontinence
  • History of pelvic surgery
  • Diabetes mellitus

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
women with metabolic syndrome and overactive bladder

women with urinary urgency+frequency+nocturia and current ATP III criteria define the metabolic syndrome as the presence of any three of the following five traits:

  1. Abdominal obesity, defined as a waist circumference in men ≥88 cm
  2. Serum triglycerides ≥150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
  3. Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL-C
  4. Blood pressure ≥130/85 mmHg or drug treatment for elevated blood pressure
  5. Fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose
women with overactive bladder
women with urinary urgency+frequency+nocturia
healthy control group
women not overactive bladder and metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nerve growth factor levels
Time Frame: 3 months
association between nerve growth factor levels and overactive bladder
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urge incontinence
Time Frame: 3 months
number of urge incontinence
3 months
overactive bladder symptoms
Time Frame: 3 months
number of nocturia,urgency,frequency
3 months

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

January 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2015

Last Update Submitted That Met QC Criteria

January 9, 2015

Last Verified

January 1, 2015

More Information

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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