Overactive BladderNCT01499069
Urinary Nerve Growth Factor (NGF), Prostaglandin E2 (PGE2)and Adenosine Triphosphate (ATP): Potential Biomarkers in Overactive Bladder Patients
A study testing Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium in people with Overactive Bladder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Feb 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients
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.
- Conditions
- Overactive Bladder
- Being tested
- Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutinin, Fesoterodine, Solifenacin, Propiverin, TrospiumDrug
Dosage and frequency can be adjusted according to the patients' symptoms based on the instruction for administration .
Duration; 3 or 6 months
| Study group | Role | What they receive |
|---|---|---|
| Antimuscarinic agents | Experimental | Not described Receives: Drug: Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium |
What is being measured
The primary outcome is the main question the study is designed to answer.
NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients.
Measured: 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
Secondary outcomes (2)
NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients.
Measured: 1 month after antimuscarinics medication and 1 months after medication completion
NGF/creatinine, PGE2/creatinine and ATP/creatinine level at pre-treatment and post-treatment of overactive bladder patients.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Biomedical Research Institute
- 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
- NCT01499069
- Sponsor's protocol ID
- 2009-09-036
- Status last verified
- Nov 2019
- First submitted
- 24 May 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
- Urinary NGF, PGE2 and ATP: Potential Biomarkers for Diagnosis and Prediction of Treatment Efficacy in Overactive Bladder Patients
- ClinicalTrials.gov ID
- NCT01499069
- Acronym / sponsor ID
- 2009-09-036
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Biomedical Research Institute
- Study start
- Feb 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antimuscarinic agents | Experimental | Drug: Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| Oxybutinin, Fesoterodine, Solifenacin, Propiverin, TrospiumDosage and frequency can be adjusted according to the patients' symptoms based on the instruction for administration . Duration; 3 or 6 months | Drug | Antimuscarinic agents |
Primary outcome
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
2 secondary outcomes
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
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)
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium in people with Overactive Bladder, run by Samsung Medical Center at 1 site 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 22 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 1 site 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?
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). 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.