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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01493401
Collaborator
(none)
137
2
1
71
68.5
1

Study Details

Study Description

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
  • Procedure: Midurethral slings (MUS)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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 :
Feb 1, 2010
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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 Names:
  • TVT, TVT-O, TOT, TVT-Secur, Needleless, etc.
  • Outcome Measures

    Primary Outcome Measures

    1. 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]

    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. [6 months after midurethral slings]

    2. Difference in urinary NGF level between pure SUI and MUI patients [Baseline]

    3. Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings [2 and 6 months after midurethral slings]

    4. Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings [2 and 6 months after midurethral slings]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    1. 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.

    1. 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

    Locations

    Site City State Country Postal Code
    1 The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital Bucheon Korea, Republic of 420-717
    2 Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Kyu-Sung Lee, Ph.D, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    KYU-SUNG LEE, Urology, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01493401
    Other Study ID Numbers:
    • 2009-11-068
    First Posted:
    Dec 16, 2011
    Last Update Posted:
    Dec 2, 2019
    Last Verified:
    Nov 1, 2019
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2019