Vesicoureteral RefluxSTRETCHNCT00830479
Study of Endoscopic Versus Open Surgery for Urinary Reflux
A study testing Anti-reflux surgery and Endoscopic injection in people with Vesicoureteral Reflux, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer… Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- Anti-reflux surgery and Endoscopic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2011
- 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 Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age <12 years
- Unilateral or Bilateral Primary VUR
- Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter
- Recommended for surgical correction of VUR by Urologist
Who cannot join
- Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR
- Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR)
- Ureterocele
- Periureteral diverticulum
- Complete duplication of duplex collecting system on side with VUR
- Prior ARS, either open or endoscopic, regardless of success or failure
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- History of other prior urinary tract surgery other than circumcision
- Solitary functional kidney
- Congenital or acquired immunodeficiency
- Chronic renal insufficiency or renal failure
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study
This study seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.
- Conditions
- Vesicoureteral Reflux
- Being tested
- Anti-reflux surgery, Endoscopic injection
- 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.
Anti-reflux surgeryProcedure or surgery
Open ureteroneocystostomy for correction of vesicoureteral reflux
Endoscopic injectionProcedure or surgery
Endoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery | Active comparator | Not described Receives: Procedure: Anti-reflux surgery |
| Endoscopic Surgery | Active comparator | Not described Receives: Procedure: Endoscopic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of VUR at 4 months
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: unable to enroll patients for randomization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830479
- Sponsor's protocol ID
- 08-08-0354
- Acronym
- STRETCH
- Status last verified
- Aug 2011
- First submitted
- 27 Jan 2009
- Last updated
- 12 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Endoscopic vs. Open Anti-Reflux Surgery For Treatment of Low-Grade Vesicoureteral Reflux: Surgical Treatment of Reflux: Endoscopic vs. Traditional CHoices (STRETCH) Study
- ClinicalTrials.gov ID
- NCT00830479
- Acronym / sponsor ID
- STRETCH / 08-08-0354
- Conditions
- Vesicoureteral Reflux
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll patients for randomization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jan 2009 (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 seeks to compare outcomes after anti-reflux surgery (ARS) for correction of low-grade vesicoureteral reflux (VUR). It is a randomized controlled open-label trial of conventional open anti-reflux technique versus endoscopic anti-reflux technique with injection of dextranomer/hyaluronic acid copolymer (Deflux). Primary endpoint will be resolution of VUR at initial cystogram after ARS. Secondary outcomes will include incidence of postoperative UTI, resolution of VUR at 1-year cystogram after ARS, surgical complications, and quality of life measures after ARS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Surgery | Active comparator | Procedure: Anti-reflux surgery |
| Endoscopic Surgery | Active comparator | Procedure: Endoscopic injection |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age <12 years
- Unilateral or Bilateral Primary VUR
- Grade 2 or 3 (VCUG) or Grade 2 (RNC) VUR in at least 1 ureter
- Recommended for surgical correction of VUR by Urologist
Key exclusion criteria (10 listed)
- Grade 4 or 5 (VCUG) or Grade 3 (RNC) VUR
- Secondary VUR (neurogenic bladder, exstrophy, or other causes of secondary VUR)
- Ureterocele
- Periureteral diverticulum
- Complete duplication of duplex collecting system on side with VUR
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 |
|---|---|---|
| Anti-reflux surgeryOpen ureteroneocystostomy for correction of vesicoureteral reflux | Procedure or surgery | Open Surgery |
| Endoscopic injectionEndoscopic injection of dextranomer/hyaluronic acid gel (Deflux) for correction of vesicoureteral reflux | Procedure or surgery | Endoscopic Surgery |
Primary outcome
Resolution of VUR at 4 months
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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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 study testing Anti-reflux surgery and Endoscopic injection in people with Vesicoureteral Reflux, run by Boston Children's Hospital at 1 site in United States.
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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 12 Aug 2011. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Resolution of VUR at 4 months (time frame: 4 months). 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 12 Aug 2011.