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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midurethral sling | Experimental | Currently available midurethral procedures for stress urinary incontinence can be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midurethral slings (MUS) | Procedure | Retropubic, Transobturator, and Single incision MUS can be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings | 6 months after midurethral slings |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after midurethral slings | |
| Difference in urinary NGF level between pure SUI and MUI patients |
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Inclusion Criteria:
Exclusion Criteria:
The subject has WBC≧3, Albumin≧+1, Nit ≧+1 upon urinalysis
On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
Patient has a significant pelvic orgen prolapse (POP) of ICS Stage 3 or over 3.
Patients with combined POP surgery.
Patients with bladder outlet obstruction on UDS or physical exam
Patients with detrusor underactivity
Diagnosed or suspected interstitial cystitis or bladder cancer
History of radiation therapy on pelvic cavity
Patients with neurologic condition which can affect lower urinary tract function
History of urogenical malignancy within recent 2 years
Treatment within the 14 days preceding enrollment, or expected to initiate treatment during the study with:
i)Any anticholinergic drugs and any drug treatment affecting lower urinary tract function Estrogen treatment started more than 2 months prior to inclusion is allowed. ii) electrostimulation, bladder training, electromagnetic treatment
Patient is on anti-coagulation therapy.
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital | Bucheon-si | 420-717 | South Korea | |||
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| ID | Term |
|---|---|
| D053825 | Suburethral Slings |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Baseline |
| Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings | 2 and 6 months after midurethral slings |
| Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings | 2 and 6 months after midurethral slings |
| Samsung Medical Center, Sungkyunkwan University School of Medicine |
| Seoul |
| 135-710 |
| South Korea |