Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT01493401|
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : December 16, 2011
Last Update Posted : February 16, 2015
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.
|Condition or disease||Intervention/treatment|
|Mixed Urinary Incontinence||Procedure: Midurethral slings (MUS)|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||January 2016|
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.
- 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 ]
- 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 ]
- Difference in urinary NGF level between pure SUI and MUI patients [ Time Frame: Baseline ]
- Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ]
- Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493401
|Contact: Kyu-Sung Lee, Ph.Dfirstname.lastname@example.org|
|Korea, Republic of|
|The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital||Recruiting|
|Bucheon, Korea, Republic of, 420-717|
|Contact: Joon Chul Kim, PhD 82-32-340-7071 email@example.com|
|Principal Investigator: Joon Chul Kim, PhD|
|Samsung Medical Center, Sungkyunkwan University School of Medicine||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Kyu-Sung Lee, MD, PhD 82-2-3410-3554 firstname.lastname@example.org|
|Principal Investigator: Kyu-Sung Lee, MD, PhD|
|Principal Investigator:||Kyu-Sung Lee, Ph.D||Samsung Medical Center|