Urinary Nerve Growth Factor (NGF), Prostaglandin E2 (PGE2)and Adenosine Triphosphate (ATP): Potential Biomarkers in Overactive Bladder Patients

This study is currently recruiting participants.
Verified January 2014 by Samsung Medical Center
Sponsor:
Collaborator:
Samsung Biomedical Research Institute
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01499069
First received: May 24, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

Nerve growth factor (NGF), prostaglandin E2 (PGE2)and adenosine triphosphate (ATP) levels in urine were reported to increase in patients with overactive bladder (OAB). Also, administration of the anti-muscarinic agent was reported to decrease urinary NGF and ATP.

The investigators aimed to explore the value of the urinary NGF, PGE2 and ATP as biomarker for predicting the treatment responsiveness and symptom relapse in OAB patients. So, the patients can be categorized into responder or non- responder and relapse or non-relapse groups. Ultimately, they can receive individualized treatments.


Condition Intervention
Overactive Bladder
Drug: Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients. [ Time Frame: 3 months after antimuscarinics medication (if, the improvement of symptoms meet the criteria of treatment completion at 3 months of medicaion) and 3 months after medication completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients. [ Time Frame: 1 month after antimuscarinics medication and 1 months after medication completion ] [ Designated as safety issue: No ]
  • NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients. [ Time Frame: 4 and 6 months after antimuscarinics medication (if, the improvement of symptoms do not met the criteria of treatment completion at 3 months of medicaion) ] [ Designated as safety issue: No ]

Estimated Enrollment: 197
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antimuscarinic agents Drug: Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium

Dosage and frequency can be adjusted according to the patients' symptoms based on the instruction for administration .

Duration; 3 or 6 months


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18 or over 18 years who had no history of antimuscarinic treatment or stopped antimuscarinics at least 3 months prior to the screening visit
  • Verified by 3-day bladder diary as below

    • Urgency episode of 2 or over 2 times/24 hours (defined as a level of 3 to 5 in a 5 point urgency scale at baseline)
    • Urinary frequency of 8 or over 8 times/24 hours
  • Symptom duration of 3 or over 3 months.
  • 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:

  • Clinically significant stress incontinence as determined by the investigators and confirmed for female patients by a cough provocation test.
  • Significant hepatic or renal disease, defined as having twice the upper limit of the reference ranges for serum concentrations of aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine
  • Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  • Symptomatic acute urinary tract infection (UTI) during the run-in period
  • Recurrent UTIs defined as having been treated for symptomatic UTIs > 4 times in the last year
  • Diagnosed or suspected interstitial cystitis
  • Uninvestigated hematuria or hematuria secondary to malignant disease.
  • Clinically significant bladder outlet obstruction defined by clinical symptoms and investigator's opinion according to local standard of care
  • Patients with marked cystocele or other clinically significant pelvic prolapse.
  • Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with:

    • Any anticholinergic drugs other than randomized trial drug
    • Any drug treatment for overactive bladder. Estrogen treatment started more than 2 months prior to inclusion is allowed.
  • On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
  • Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
  • An indwelling catheter or practicing intermittent self-catheterization
  • Use of any investigational drug within 2 months preceding the start of the study
  • Patients with chronic constipation or history of severe constipation
  • Pregnant or nursing women
  • Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter. Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
  • Patients who have bladder cancer or prostate cancer
  • Treatment with potent CYP3A4 inhibitors, such as cyclosporine, vinblastine, macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin) or antifungal agents (e.g. ketoconazole, itraconazole, micronazole).
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499069

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

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, Ph.D    82-2-3410-3554    ksleedr@skku.edu   
Contact: Bong-Hee Lim, BA    82-2-3410-3743    bonghee.lim@sbri.co.kr   
Sub-Investigator: Deok Hyun Han, PhD         
Sub-Investigator: Young-Suk Lee, PhD         
Sub-Investigator: Ha Na Lee, PhD         
Sponsors and Collaborators
Samsung Medical Center
Samsung Biomedical Research Institute
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Professor of Urology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01499069     History of Changes
Other Study ID Numbers: 2009-09-036
Study First Received: May 24, 2011
Last Updated: January 8, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Muscarinic Antagonists
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Propiverine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014