Neurogenic Lower Urinary Tract DysfunctionPhase 4NCT02034604
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
A Phase 4 study testing Naftofidil and Tamsulosin in people with Neurogenic Lower Urinary Tract Dysfunction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neurogenic Lower Urinary Tract Dysfunction
- What is being tested?
- Naftofidil and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Aug 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 20 years old and above (upper limit of age: 80 years old)
- patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
- a+b
- IPSS ≥ 12 and QoL ≥ 3
- Maximum Flow Rate <15 mL/s (Voiding volume) ≥ 120mL)
- 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
- In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
- In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
- In female, the history of anti-incontinence operation.
- Patients with cancer of any type including cancer of the prostate or bladder
- Patients with urethral stricture or bladder neck contracture
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.
- Being tested
- Naftofidil, Tamsulosin
- Keywords
- Naftopidil, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaftofidilDrug
TamsulosinDrug
| Study group | Role | What they receive |
|---|---|---|
| Naftopidil Group | Experimental | Naftopidil medication patients Receives: Drug: Naftofidil |
| Tamsulosin Goup | Active comparator | Tamsulosin medication patients Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients' symptom questionnaires
international prostate symptom score (IPSS) change, except QOL domain scores
Measured: from baseline to 8 weeks of treatment
Secondary outcomes (8)
Changes in uroflow parameters
maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR
Measured: from baseline to 8 weeks of treatment
Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.
Measured: from baseline to 8 weeks of treatment
Benefit, Satisfaction, and Willingness to Continue (BSW) questions
Measured: 8 weeks after treatment
Score of global response assessment for Korean, GRA-K
Measured: 8 weeks after treatment
Treatment satisfaction question, TSQ
Measured: 8 weeks after treatment
safety evaluation : incidence and severity of adverse events
Measured: up to 8 weeks
change in each domain scores of IPSS
Measured: up to 8 weeks
change in number of urinary frequency, nocturia
Measured: up to 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Lower Urinary Tract DysfunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034604
- Sponsor's protocol ID
- 2013-02-043
- Status last verified
- Nov 2019
- First submitted
- 9 Jan 2014
- 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
- Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02034604
- Acronym / sponsor ID
- 2013-02-043
- Keywords
- Naftopidil, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jan 2014 (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.
This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naftopidil Group | Experimental | Drug: NaftofidilNaftopidil medication patients |
| Tamsulosin Goup | Active comparator | Drug: TamsulosinTamsulosin medication patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 20 years old and above (upper limit of age: 80 years old)
- patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
- a+b
- 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 (5 listed)
- In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
- In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
- In female, the history of anti-incontinence operation.
- Patients with cancer of any type including cancer of the prostate or bladder
- Patients with urethral stricture or bladder neck contracture
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 |
|---|---|---|
| Naftofidil | Drug | Naftopidil Group |
| Tamsulosin | Drug | Tamsulosin Goup |
Primary outcome
Changes in patients' symptom questionnaires
Time frame: from baseline to 8 weeks of treatment
international prostate symptom score (IPSS) change, except QOL domain scores
8 secondary outcomes
Changes in uroflow parameters
Time frame: from baseline to 8 weeks of treatment
Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.
Time frame: from baseline to 8 weeks of treatment
Benefit, Satisfaction, and Willingness to Continue (BSW) questions
Time frame: 8 weeks after treatment
Score of global response assessment for Korean, GRA-K
Time frame: 8 weeks after treatment
Treatment satisfaction question, TSQ
Time frame: 8 weeks after treatment
safety evaluation : incidence and severity of adverse events
Time frame: up to 8 weeks
change in each domain scores of IPSS
Time frame: up to 8 weeks
change in number of urinary frequency, nocturia
Time frame: up to 8weeks
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naftofidil and Tamsulosin in people with Neurogenic Lower Urinary Tract Dysfunction, 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 5 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.
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?
Changes in patients' symptom questionnaires (time frame: from baseline to 8 weeks of treatment). 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.