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

Primary Purpose

Mixed Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Midurethral slings (MUS)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mixed Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital
  • Samsung Medical Center, Sungkyunkwan University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Midurethral sling

Arm Description

Currently available midurethral procedures for stress urinary incontinence can be used.

Outcomes

Primary Outcome Measures

Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings

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.
Difference in urinary NGF level between pure SUI and MUI patients
Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings
Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings

Full Information

First Posted
December 14, 2011
Last Updated
November 28, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01493401
Brief Title
Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Urinary Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Midurethral sling
Arm Type
Experimental
Arm Description
Currently available midurethral procedures for stress urinary incontinence can be used.
Intervention Type
Procedure
Intervention Name(s)
Midurethral slings (MUS)
Other Intervention Name(s)
TVT, TVT-O, TOT, TVT-Secur, Needleless, etc.
Intervention Description
Retropubic, Transobturator, and Single incision MUS can be used.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Difference in urinary NGF level between pure SUI and MUI patients
Time Frame
Baseline
Title
Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings
Time Frame
2 and 6 months after midurethral slings
Title
Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings
Time Frame
2 and 6 months after midurethral slings

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital
City
Bucheon
ZIP/Postal Code
420-717
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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