Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Mixed Urinary Incontinence Procedure: Midurethral slings (MUS) Not Applicable

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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Difference in urinary NGF level between pure SUI and MUI patients [ Time Frame: Baseline ]
  3. Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ]
  4. Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings [ Time Frame: 2 and 6 months after midurethral slings ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01493401

Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554

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   
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   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

Responsible Party: KYU-SUNG LEE, Urology, Professor, Samsung Medical Center Identifier: NCT01493401     History of Changes
Other Study ID Numbers: 2009-11-068
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: January 2014

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action