Lower Urinary Tract Obstructive SyndromePhase 2CYSTUONCT01552824
Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
A Phase 2 study testing CYSTO and Vesico-amniotic shunt in people with Lower Urinary Tract Obstructive Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Lower Urinary Tract Obstructive Syndrome
- What is being tested?
- CYSTO and Vesico-amniotic shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jun 2018
- Phase
- Phase 2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- single pregnancy
- male fetuses
- gestational age dating by ultrasound examination performed before 20 weeks
- confirmed severe LUTO (see details before)
- severe oligohydramnios (AFI<5.0cm)
- no other structural anomalies by complete fetal anatomy ultrasound scan and fetal echocardiogram
- no abnormal karyotype
- 'favorable' urine analysis (urinary sodium <100 mEq/L, chloride <90 mEq/L, osmolarity <200 mOsm/L) when gestational age >20 weeks
Who cannot join
- presence of other anomalies diagnosed after fetal intervention
- maternal refusal to participate in the present protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-010
About this study
Official title: Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.
Read the detailed description
Objectives: To evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy of the posterior urethral valves and to compare with the results of vesicoamniotic shunting.
Outcomes: Accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves, neonatal and infant survival (6 and 12 months), as well as normal renal function during the same ages.
Study design: Randomized controlled trial. Methods: Pregnant women whose fetuses have isolated and severe lower urinary tract obstruction (LUTO) with (oligohydramnios and severe hydronephrosis) will be invited to participate in the present study. Patients will be randomized into the fetal cystoscopic group (CYSTO) vs vesico-amniotic shunting (VAS). The investigators intend to enroll 30 patients in each group (a total of 60). All patients will be followed by fetal ultrasound each 15 days. Besides, these infants will be followed up to one year of age. Maternal and obstetrical complications are going to be evaluated as well as neonatal and infant survival and the renal function.
- Conditions
- Lower Urinary Tract Obstructive Syndrome
- Being tested
- CYSTO, Vesico-amniotic shunt
- Keywords
- LUTO, posterior urethral valves, urethral atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYSTOProcedure or surgery
Fetal cystoscopy will be performed by introducing a 2.2mm sheath with 1.0mm fetoscope into fetal bladder under ultrasound guidance. The fetoscope will be advanced and the posterior urethral valves will be coagulated by ND:YAG laser. If urethra atresia was diagnosed, a vesico-amniotic shunting will be placed. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
Vesico-amniotic shuntProcedure or surgery
In this arm, all patients randomly selected for this treatment will undergo vesico-amniotic shunting under ultrasound guidance. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
| Study group | Role | What they receive |
|---|---|---|
| Vesico-amniotic shunt | Experimental | In this arm, patients will be randomly selected to undergo vesico-amniotic shunting. Receives: Procedure: Vesico-amniotic shunt |
| CYSTO | Experimental | In this arm, all patients will be randomly selected for fetal cystoscopy. Receives: Procedure: CYSTO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal survival rate
The primary outcome is survival from the treatment to the neonatal period (up to 28 days of life). Therefore, the objective is to evaluate the safety and effectiveness of both therapeutic options.
Measured: from fetal period to neonatal perid (up to 28 days after birth)
Neonatal renal function
Renal function will be evaluated by serum creatine and urinalysis in the neonates, as well as by micturating cystourethrography and postnatal cystoscopy after birth up to 28 days of life.
Measured: up to 28 days of life
Secondary outcomes (4)
Survival rate at 6 months
The survival rate up to 6 months of life will be evaluated.
Measured: Up to 6 months of life
Renal function at 6 months of life
Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
Measured: 6 months of life
Survival rate at 1 year of age
The survival rate will be evaluated at 1 year of age.
Measured: 1 year of age
Renal function at 1 year of age
Renal function will be evaluated by serum creatinine, need for dialysis and/or renal transplantation.
Measured: 1 year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJun 2015
- Primary completionMay 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract Obstructive SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Ruano, University of Sao Paulo General Hospital
- Investigators
- Rodrigo Ruano, MD, PhD, Principal investigator, Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552824
- Sponsor's protocol ID
- 0853/11
- Other IDs
- 0853/11
- Acronym
- CYSTUO
- Status last verified
- May 2015
- First submitted
- 9 Mar 2012
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruano R, Pimenta EJ, Duarte S, Zugaib M. Four-dimensional ultrasonographic imaging of fetal lower urinary tract obstruction and guidance of percutaneous cystoscopy. Ultrasound Obstet Gynecol. 2009 Feb;33(2):250-2. doi: 10.1002/uog.6292. No abstract available.
PubMed 19173237Ruano R, Duarte S, Bunduki V, Giron AM, Srougi M, Zugaib M. Fetal cystoscopy for severe lower urinary tract obstruction--initial experience of a single center. Prenat Diagn. 2010 Jan;30(1):30-9. doi: 10.1002/pd.2418.
PubMed 19967749Ruano R, Yoshisaki CT, Salustiano EM, Giron AM, Srougi M, Zugaib M. Early fetal cystoscopy for first-trimester severe megacystis. Ultrasound Obstet Gynecol. 2011 Jun;37(6):696-701. doi: 10.1002/uog.8963.
PubMed 21337440Morris RK, Ruano R, Kilby MD. Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Ultrasound Obstet Gynecol. 2011 Jun;37(6):629-37. doi: 10.1002/uog.8981. Epub 2011 May 16.
PubMed 21374748Ruano R. Fetal surgery for severe lower urinary tract obstruction. Prenat Diagn. 2011 Jul;31(7):667-74. doi: 10.1002/pd.2736. Epub 2011 Mar 17.
PubMed 21413041
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Fetal Cystoscopy Versus Vesico-amniotic Shunting in Severe Lower Urinary Tract Obstructions
- ClinicalTrials.gov ID
- NCT01552824
- Acronym / sponsor ID
- CYSTUO / 0853/11
- Conditions
- Lower Urinary Tract Obstructive Syndrome
- Keywords
- LUTO, posterior urethral valves, urethral atresia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 13 Mar 2012 (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.
There are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. There is no study confirming the effectiveness of these treatment, specially comparing both techniques. The present study aims to investigate the effectiveness of these treatments.
Detailed description
Objectives: To evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy of the posterior urethral valves and to compare with the results of vesicoamniotic shunting.
Outcomes: Accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves, neonatal and infant survival (6 and 12 months), as well as normal renal function during the same ages.
Study design: Randomized controlled trial. Methods: Pregnant women whose fetuses have isolated and severe lower urinary tract obstruction (LUTO) with (oligohydramnios and severe hydronephrosis) will be invited to participate in the present study. Patients will be randomized into the fetal cystoscopic group (CYSTO) vs vesico-amniotic shunting (VAS). The investigators intend to enroll 30 patients in each group (a total of 60). All patients will be followed by fetal ultrasound each 15 days. Besides, these infants will be followed up to one year of age. Maternal and obstetrical complications are going to be evaluated as well as neonatal and infant survival and the renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vesico-amniotic shunt | Experimental | Procedure: Vesico-amniotic shuntIn this arm, patients will be randomly selected to undergo vesico-amniotic shunting. |
| CYSTO | Experimental | Procedure: CYSTOIn this arm, all patients will be randomly selected for fetal cystoscopy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- single pregnancy
- male fetuses
- gestational age dating by ultrasound examination performed before 20 weeks
- confirmed severe LUTO (see details before)
- severe oligohydramnios (AFI<5.0cm)
Key exclusion criteria (2 listed)
- presence of other anomalies diagnosed after fetal intervention
- maternal refusal to participate in the present protocol
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 |
|---|---|---|
| CYSTOFetal cystoscopy will be performed by introducing a 2.2mm sheath with 1.0mm fetoscope into fetal bladder under ultrasound guidance. The fetoscope will be advanced and the posterior urethral valves will be coagulated by ND:YAG laser. If urethra atresia was diagnosed, a vesico-amniotic shunting will be placed. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle. | Procedure or surgery | CYSTO |
| Vesico-amniotic shuntIn this arm, all patients randomly selected for this treatment will undergo vesico-amniotic shunting under ultrasound guidance. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle. | Procedure or surgery | Vesico-amniotic shunt |
Primary outcome
Perinatal survival rate
Time frame: from fetal period to neonatal perid (up to 28 days after birth)
The primary outcome is survival from the treatment to the neonatal period (up to 28 days of life). Therefore, the objective is to evaluate the safety and effectiveness of both therapeutic options.
Neonatal renal function
Time frame: up to 28 days of life
Renal function will be evaluated by serum creatine and urinalysis in the neonates, as well as by micturating cystourethrography and postnatal cystoscopy after birth up to 28 days of life.
4 secondary outcomes
Survival rate at 6 months
Time frame: Up to 6 months of life
Renal function at 6 months of life
Time frame: 6 months of life
Survival rate at 1 year of age
Time frame: 1 year of age
Renal function at 1 year of age
Time frame: 1 year of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 19173237Ruano R, Pimenta EJ, Duarte S, Zugaib M. Four-dimensional ultrasonographic imaging of fetal lower urinary tract obstruction and guidance of percutaneous cystoscopy. Ultrasound Obstet Gynecol. 2009 Feb;33(2):250-2. doi: 10.1002/uog.6292. No abstract available.
- Background: PubMed 19967749Ruano R, Duarte S, Bunduki V, Giron AM, Srougi M, Zugaib M. Fetal cystoscopy for severe lower urinary tract obstruction--initial experience of a single center. Prenat Diagn. 2010 Jan;30(1):30-9. doi: 10.1002/pd.2418.
- Background: PubMed 21337440Ruano R, Yoshisaki CT, Salustiano EM, Giron AM, Srougi M, Zugaib M. Early fetal cystoscopy for first-trimester severe megacystis. Ultrasound Obstet Gynecol. 2011 Jun;37(6):696-701. doi: 10.1002/uog.8963.
- Background: PubMed 21374748Morris RK, Ruano R, Kilby MD. Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Ultrasound Obstet Gynecol. 2011 Jun;37(6):629-37. doi: 10.1002/uog.8981. Epub 2011 May 16.
- Background: PubMed 21413041Ruano R. Fetal surgery for severe lower urinary tract obstruction. Prenat Diagn. 2011 Jul;31(7):667-74. doi: 10.1002/pd.2736. Epub 2011 Mar 17.
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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.
Rodrigo Ruano, MD, PhD principal investigator
Faculdade de Medicina da Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYSTO and Vesico-amniotic shunt in people with Lower Urinary Tract Obstructive Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 May 2015. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenia MA Salustiano, RN ((5511)2661-6209, eugeniaassuncao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal survival rate (time frame: from fetal period to neonatal perid (up to 28 days after birth)). The study lists 2 primary outcomes in all. 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 NCT01552824, which also lists 5 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 12 May 2015.