Mixed Urinary IncontinenceNCT01493401
Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence
A study testing Midurethral slings (MUS) in people with Mixed Urinary Incontinence, run by Samsung Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mixed Urinary Incontinence
- What is being tested?
- Midurethral slings (MUS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Feb 2010to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital
Bucheon-si, 420-717
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
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
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).
Read more
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.
- Conditions
- Mixed Urinary Incontinence
- Being tested
- Midurethral slings (MUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midurethral slings (MUS)Procedure or surgery
Also called TVT, TVT-O, TOT, TVT-Secur, Needleless, etc.
Retropubic, Transobturator, and Single incision MUS can be used.
| Study group | Role | What they receive |
|---|---|---|
| Midurethral sling | Experimental | Currently available midurethral procedures for stress urinary incontinence can be used. Receives: Procedure: Midurethral slings (MUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the baseline urinary NGF level between patients with and without urgency incontinence at 6 months after midurethral slings
Measured: 6 months after midurethral slings
Secondary outcomes (4)
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.
Measured: 6 months after midurethral slings
Difference in urinary NGF level between pure SUI and MUI patients
Measured: Baseline
Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings
Measured: 2 and 6 months after midurethral slings
Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings
Measured: 2 and 6 months after midurethral slings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startFeb 2010
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493401
- Sponsor's protocol ID
- 2009-11-068
- Status last verified
- Nov 2019
- First submitted
- 14 Dec 2011
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01493401
- Acronym / sponsor ID
- 2009-11-068
- Conditions
- Mixed Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midurethral sling | Experimental | Procedure: Midurethral slings (MUS)Currently available midurethral procedures for stress urinary incontinence can be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midurethral slings (MUS)Also: TVT, TVT-O, TOT, TVT-Secur, Needleless, etc.Retropubic, Transobturator, and Single incision MUS can be used. | Procedure or surgery | Midurethral sling |
Primary outcome
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
4 secondary outcomes
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
Difference in urinary NGF level between pure SUI and MUI patients
Time frame: Baseline
Changes in OAB symptoms (including urgency incontinence) and SUI after midurethral slings
Time frame: 2 and 6 months after midurethral slings
Correlation between changes in urinary NGF and OAB symptoms (including urgency incontinence) after midurethral slings
Time frame: 2 and 6 months after midurethral slings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midurethral slings (MUS) in people with Mixed Urinary Incontinence, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.