Status:
COMPLETED
Urinary Urinary Nerve Growth Factor (NGF) as a Biomarker for Mixed Urinary Incontinence
Lead Sponsor:
Samsung Medical Center
Conditions:
Mixed Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01493401
Start Date
February 1 2010
End Date
January 1 2016
Last Update
December 2 2019
Active Locations (2)
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1
The Catholic University of Korea College of Medicine, Bucheon St. Mary's Hospital
Bucheon-si, South Korea, 420-717
2
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710