Vesicoureteral RefluxNCT00815334
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
A study testing Endoscopic subureteric injection in people with Vesicoureteral Reflux, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- Endoscopic subureteric injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Dec 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who is aged 18 and greater
- Who underwent endoscopic subureteral injection for vesicoureteral reflux
Who cannot join
- Medical records of whom is not evaluabe
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.
- Conditions
- Vesicoureteral Reflux
- Being tested
- Endoscopic subureteric injection
- Keywords
- vesicoureteral reflux, low compliant bladder
- Medical subject headings
- Vesico-Ureteral Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic subureteric injectionProcedure or surgery
Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
| Study group | Role | What they receive |
|---|---|---|
| Patients with decreased bladder compliance | Experimental | Patients who have decreased bladder compliance Receives: Procedure: Endoscopic subureteric injection |
| Patients with normal bladder compliance | Active comparator | Patients who have normal bladder compliance Receives: Procedure: Endoscopic subureteric injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Measured: 3, 12 months
Secondary outcomes (2)
adverse events
Measured: 3, 12 months
predictive factor for cure
Measured: 3, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vesicoureteral RefluxStudies 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
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kyu-Sung Lee, Ph.D., M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815334
- Sponsor's protocol ID
- 2008-10-094
- Status last verified
- Feb 2009
- First submitted
- 28 Dec 2008
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9. doi: 10.1016/j.eururo.2003.11.025.
PubMed 15149753Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21. doi: 10.1016/j.juro.2006.07.076.
PubMed 17070296Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.
PubMed 11148731
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
- ClinicalTrials.gov ID
- NCT00815334
- Acronym / sponsor ID
- 2008-10-094
- Conditions
- Vesicoureteral Reflux
- Keywords
- vesicoureteral reflux, low compliant bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Dec 2008 (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.
Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with decreased bladder compliance | Experimental | Procedure: Endoscopic subureteric injectionPatients who have decreased bladder compliance |
| Patients with normal bladder compliance | Active comparator | Procedure: Endoscopic subureteric injectionPatients who have normal bladder compliance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Who is aged 18 and greater
- Who underwent endoscopic subureteral injection for vesicoureteral reflux
Key exclusion criteria (1 listed)
- Medical records of whom is not evaluabe
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 |
|---|---|---|
| Endoscopic subureteric injectionEndoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer) | Procedure or surgery | Patients with decreased bladder compliance, Patients with normal bladder compliance |
Primary outcome
Cure rate
Time frame: 3, 12 months
2 secondary outcomes
adverse events
Time frame: 3, 12 months
predictive factor for cure
Time frame: 3, 12 months
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 17 Jun 2009.
- Background: PubMed 15149753Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9. doi: 10.1016/j.eururo.2003.11.025.
- Background: PubMed 17070296Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21. doi: 10.1016/j.juro.2006.07.076.
- Background: PubMed 11148731Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.
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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., M.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 Endoscopic subureteric injection in people with Vesicoureteral Reflux, 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 2 inclusion and 1 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 17 Jun 2009. 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?
Cure rate (time frame: 3, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815334, which also lists 3 linked publications.
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 17 Jun 2009.