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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01493401
First received: December 14, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention
Mixed Urinary Incontinence
Procedure: Midurethral slings (MUS)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 121
Study Start Date: February 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493401

Contacts
Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu

Locations
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    kjc@catholic.ac.kr   
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    ksleedr@skku.edu   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Urology, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01493401     History of Changes
Other Study ID Numbers: 2009-11-068
Study First Received: December 14, 2011
Last Updated: January 8, 2014
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014