- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335853
Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder (NGF)
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Bakirkoy
-
Istanbul, Bakirkoy, Turkey, 34140
- Recruiting
- Bakirkoy Dr Sadi Konuk Training and Research Hospital
-
Contact:
- hediye dagdeviren, md
- Phone Number: 5536161385
- Email: hediyedagdeviren@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/11/02
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.
Clinical Trials on Overactive Bladder
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
-
Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
-
Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
-
Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
-
Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
-
Beijing Pins Medical Co., LtdUnknown
-
Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
-
Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey