Exploration of the Potential of Urinary Nerve Growth Factor (NGF) as a Biomarker for Diagnosis and Prognosis of Mixed Urinary Incontinence After Midurethral Slings
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mixed Urinary Incontinence
- Sponsor
- Samsung Medical Center
- Enrollment
- 137
- Locations
- 2
- Primary Endpoint
- Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
KYU-SUNG LEE
Urology, Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Women aged 18 or over 18 years with MUI for 3 or over 3 months
- •Proven SUI by urodynamic study (UDS)or stress test
- •Abdominal leak point pressure (ALPP)of 120 or less than 120cmH2O in UDS
- •Symptoms verified using 5 day bladder diary as below i) number of urgency incontinence; 3 or more than 3/5days ii) number of micturition; 8 or more than 8/24hrs iii) number of urgency; 2 or more than 2/24hrs
- •Women who cannot be pregnant or do not have plan to be pregnant
- •Ability and willingness to correctly complete the micturition diary and questionnaire
- •Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
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
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Difference in urinary NGF level between pure SUI and MUI patients(Baseline)
- Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings(2 and 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.(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)