Neurogenic BladderPhase 4NCT01228370
Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
A Phase 4 study testing silodosin in people with Neurogenic Bladder and Voiding Dysfunction, run by JW Pharmaceutical at 6 sites in South Korea.
Trial summary
Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors, α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with or without neurogenic bladder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neurogenic Bladder, Voiding Dysfunction
- What is being tested?
- silodosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Apr 2011to Jan 2012
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who is 20 years old or over
- Patient who is diagnosed with neurogenic bladder through urodynamic test, having urinary disorder symptoms
- In case, patient has been taking concomitant drugs allowed for the study, only if the doses have been stable within 8 weeks from the screening visit
- Patient who has a I-PSS score of 8 or over
- Patient who has a QoL score of 3 or over
- Patient who has a Qmax of below 15 mL/sec
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- Patient who has a PSA<4.0 ng/mL or has PSA>4.0 ng/mL with no opinion of prostate cancer from biopsy
- Patient who is willing to take the investigational product in accordance with the protocol
- Patient who is able to fill out questionnaire and understand requirements of the study including informed consent
- Patient voluntarily decides to participate and signs the written consent form.
Who cannot join
- Patient who hs urinate at all on his/her own.
- Patient who has a history of bladder surgery
- Patient who has detrusor areflexia or acontractile bladder diagnosed by urodynamic test
- Patient who has a postvoid residual urine volume(PRV) of 300 mL or greater, or has a PRV of 50% or over of the maximum bladder capacity
- Patient who has a prostate volume of 30 mL or greater resulted from a severe benign prostatic hyperplasia(BPH) (only in case of male)
- Patient who has urethral stricture
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- Patient who has symptomatic urinary tract infection(UTI) before screening visit
- Patient who has a gross hematuria(except idiopathic hematuria)
- Patient who conducts Clean Intermittent Catheterization(CIC)
- Patient who has been taking α-blocker other than silodosin or α-agonist within 8 weeks from screening visit
- Patient who has a Botulinum toxin injection for bladder problems within at least 1 year from screening visit
- Patient who has severe hapatic disorders(hepatic insufficiency, cirrhosis, jaundice, hepatoma)or has a total bilirubin of 2.5 mg/dL or higher or has AST/ALT 2.5 times higher than the normal upper limit
- Patient who has a renal impairment with a serum creatinine 2.0 mg/dL or higher
- Patient who has experienced severe arrhythmia, cardiac failure, myocardiac infarction, unstable angina, cerebral infarction within 6 months from screening visit
- Patient who has orthostatic hypotention before screening visit
- Patient who has a demanding chronic disease
- Patient who has an allergy to drugs
- Patient who is prohibited from taking silodosin
- Patient who has to take drugs prohibited from the study during the clinical study
- Patient who is pregnant or plans to be pregnant or is breastfeeding or is not practicing contraception using medically acceptable contracenption
- Patient who has experienced any other clinical study within 4 weeks from screening visit
- Patient who is excluded from medical dicisions made by the investigators
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Samsung Changwon Hospital
Changwon, Gyeongsangnam-do
Daegu Catholic Univ. Medical Center
Daegu, Daegu City
Daegu Fatima Hospital
Daegu, Daegu City
Keimyung Univ. Dongsan Medical Center
Daegu, Daegu City
Yeungnam Univ. Medical Center
Daegu, Daegu City
Ulsan Univ. Hospital
Ulsan, Ulsan City
About this study
Official title: A 12-week, Open-label, Multi-center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors, α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with or without neurogenic bladder.
α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in patients with neurogenic bladder.
Based on these turnouts, we designed this clinical study to evaluate the clinical effect and safety of silodosin on voiding dysfunction associated with neurogenic bladder.
- Conditions
- Neurogenic Bladder, Voiding Dysfunction
- Being tested
- silodosin
- Keywords
- sildosin, neurogenic bladder, voiding dysfunction
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silodosinDrug
silodosin 8mg once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Experimental | Silodosin 8mg once a day for 12 weeks Receives: Drug: silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-PSS score change after treatment
Measured: 12 weeks
Secondary outcomes (3)
Change in Qmax after treatment
Measured: 12 weeks
Change in Postvoid Residual urine Volume(PRV) after treatment
Measured: 12 weeks
Change in I-PSS Quality of Life after treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Duk-Yoon Kim, Principal investigator, Daegu Catholic University Medical CenterChul-Hee Park, Principal investigator, Keimyung Univ. Dongsan Medical CenterHee-Chang Jung, Principal investigator, Yeungnam Univ. Medical CenterKyung-Hyun Moon, Principal investigator, Ulsan Univ. HospitalTae-Hee Oh, Principal investigator, Samsung Changwon HospitalJae-Soo Kim, Principal investigator, Daegu Fatima Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228370
- Sponsor's protocol ID
- CWP-SDS-402
- Status last verified
- Oct 2010
- First submitted
- 25 Oct 2010
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Open-label, Multi-center Study to Evaluate the Clinical Efficacy and Safety of Silodosin on Voiding Dysfunction Associated With Neurogenic Bladder
- ClinicalTrials.gov ID
- NCT01228370
- Acronym / sponsor ID
- CWP-SDS-402
- Conditions
- Neurogenic Bladder, Voiding Dysfunction
- Keywords
- sildosin, neurogenic bladder, voiding dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Oct 2010 (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.
Because the bladder neck and proximal urethra contain abundant α1-adrenergic receptors, α-blockers or α1-blockers are well-known to reduce bladder neck obstruction in patients with or without neurogenic bladder.
α1-blockers seem to have a potential to reduce bladder outlet resistance during voiding in patients with neurogenic bladder.
Based on these turnouts, we designed this clinical study to evaluate the clinical effect and safety of silodosin on voiding dysfunction associated with neurogenic bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Experimental | Drug: silodosinSilodosin 8mg once a day for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient who is 20 years old or over
- Patient who is diagnosed with neurogenic bladder through urodynamic test, having urinary disorder symptoms
- In case, patient has been taking concomitant drugs allowed for the study, only if the doses have been stable within 8 weeks from the screening visit
- Patient who has a I-PSS score of 8 or over
- Patient who has a QoL score of 3 or over
Key exclusion criteria (22 listed)
- Patient who hs urinate at all on his/her own.
- Patient who has a history of bladder surgery
- Patient who has detrusor areflexia or acontractile bladder diagnosed by urodynamic test
- Patient who has a postvoid residual urine volume(PRV) of 300 mL or greater, or has a PRV of 50% or over of the maximum bladder capacity
- Patient who has a prostate volume of 30 mL or greater resulted from a severe benign prostatic hyperplasia(BPH) (only in case of male)
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 |
|---|---|---|
| silodosinsilodosin 8mg once a day for 12 weeks | Drug | Silodosin |
Primary outcome
I-PSS score change after treatment
Time frame: 12 weeks
3 secondary outcomes
Change in Qmax after treatment
Time frame: 12 weeks
Change in Postvoid Residual urine Volume(PRV) after treatment
Time frame: 12 weeks
Change in I-PSS Quality of Life after treatment
Time frame: 12 weeks
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 5 Oct 2012.
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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.
Duk-Yoon Kim principal investigator
Daegu Catholic University Medical Center
Chul-Hee Park principal investigator
Keimyung Univ. Dongsan Medical Center
Hee-Chang Jung principal investigator
Yeungnam Univ. Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing silodosin in people with Neurogenic Bladder and Voiding Dysfunction, run by JW Pharmaceutical at 6 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 10 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 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
I-PSS score change after treatment (time frame: 12 weeks). 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 5 Oct 2012.