Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence
Recruitment status was: Recruiting
Female urinary incontinence (UI) can be caused by pure stress UI (SUI), pure urgency UI (UUI) and mixed SUI and UUI (MUI). Clinically it might not be that easy to separate MUI and SUI. Patients might perceive urgency when they have an incompetent urethra and a full bladder.
Urinary tract nerve growth factor (NGF)is produced by bladder urothelium and smooth muscle. Increased levels of NGF have been reported in the bladder tissue and urine of patients with overactive bladder (OAB).
If the urinary levels of NGF differ among women with pure SUI and MUI, then urinary NGF level might be a biomarker in the differential diagnosis of MUI in women.
Also, decreased urinary NGF level was reported in OAB patients of whom the symptoms were improved. So, we might expect that the remnant OAB symptom including urgency incontinence can be improved, if the urinary NGF levels decrease after midurethral slings for SUI in MUI patients.
We aimed to explore the value of the urinary NGF as a biomarker for differential diagnosis and as a prognostic marker for predicting the improvement of OAB symptom after midurethral slings.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Exploration of the Potential of Urinary Nerve Growth Factor (NGF) as a Biomarker for Diagnosis and Prognosis of Mixed Urinary Incontinence After Midurethral Slings|
- Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings [ Time Frame: 6 months after midurethral slings ] [ Designated as safety issue: No ]
- Baselinec cut-off value of urinary NGF level which can predict the patients whose urgency incontinence will be cured and whose urgency incontinence will not be cured. [ Time Frame: 6 months after midurethral slings ] [ Designated as safety issue: No ]
- Difference in urinary NGF level between pure SUI and MUI patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ] [ Designated as safety issue: No ]
- Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Midurethral sling
Currently available midurethral procedures for stress urinary incontinence can be used.
Procedure: Midurethral slings (MUS)
Retropubic, Transobturator, and Single incision MUS can be used.
Other Name: TVT, TVT-O, TOT, TVT-Secur, Needleless, etc.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493401
|Korea, Republic of|
|The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital|
|Bucheon, Korea, Republic of, 420-717|
|Samsung Medical Center, Sungkyunkwan University School of Medicine|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Kyu-Sung Lee, Ph.D||Samsung Medical Center|