NCT02335853

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 2, 2015

Last Update Submit

January 9, 2015

Conditions

Overactive Bladder

Keywords

urinary bladdernerve growth factoroveractive bladder

Outcome Measures

Primary Outcomes (1)

  • nerve growth factor levels

    association between nerve growth factor levels and overactive bladder

    3 months

Secondary Outcomes (2)

  • urge incontinence

    3 months

  • overactive bladder symptoms

    3 months

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women with overactive bladder

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi Konuk Training and Research Hospital

Istanbul, Bakirkoy, 34140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, OveractiveHereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 12, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

TU(1)