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

Overactive Bladder Clinical Trial

— NGF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02335853
• Other study ID #: 2014/11/02
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2015
• Last updated: January 9, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Overactive Bladder
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Training and Research Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nerve growth factor levels	association between nerve growth factor levels and overactive bladder	3 months	No
Secondary	urge incontinence	number of urge incontinence	3 months	No
Secondary	overactive bladder symptoms	number of nocturia,urgency,frequency	3 months	No