Overactive BladderNGFNCT02335853
Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder
An observational study of Overactive Bladder, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with overactive bladder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Bakirkoy, 34140
hediye dagdeviren, md, 5536161385, hediyedagdeviren@gmail.com
huseyin cengiz, md
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder
- Keywords
- urinary bladder, nerve growth factor, overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
nerve growth factor levels
association between nerve growth factor levels and overactive bladder
Measured: 3 months
Secondary outcomes (2)
urge incontinence
number of urge incontinence
Measured: 3 months
overactive bladder symptoms
number of nocturia,urgency,frequency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335853
- Sponsor's protocol ID
- 2014/11/02
- Acronym
- NGF
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2015
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Metabolic Syndrome and Serum Nerve Growth Factor Levels in Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT02335853
- Acronym / sponsor ID
- NGF / 2014/11/02
- Conditions
- Overactive Bladder
- Keywords
- urinary bladder, nerve growth factor, overactive bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with overactive bladder
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Chronic obstructive pulmonary disease allergy
- Psychiatric disorders
- Urinary tract infection
- Neurological diseases
- Metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
nerve growth factor levels
Time frame: 3 months
association between nerve growth factor levels and overactive bladder
2 secondary outcomes
urge incontinence
Time frame: 3 months
overactive bladder symptoms
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bakirkoy Dr Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nerve growth factor levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.