Lower Urinary Tract Obstructive SyndromeCYSTONCT03281798
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
A study testing Fetoscopes and Fetal Cystoscopy in people with Lower Urinary Tract Obstructive Syndrome and Lower Urinary Tract Obstruction, Congenital, run by Rodrigo Ruano at 2 sites in United States.
Trial summary
The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction
- What is being tested?
- Fetoscopes and Fetal Cystoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2018to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women
- Singleton pregnancy
- Maternal age ≥ 18 years
- Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
- Oligohydramnios or Anhydramnios
- Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).
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- Absence of chromosomal abnormalities and associated anomalies
- Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
- Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
- Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
- Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
- Parents or guardian are willing to provide signed informed consent.
Who cannot join
- Fetal anomaly unrelated to LUTO
- Congenital cardiac anomaly
- Female fetus
- Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Contraindications to surgery including previous hysterotomy in active uterine segment
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- Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
- Maternal medical condition that is a contraindication to surgery or anesthesia
- Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
- Inability to comply with travel and follow-up requirements of the trial
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
- Patients declining invasive testing
- Family does not meet psychosocial criteria including insufficient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Rodrigo Ruano, MD, Ph.D, 305-243-0769, rodrigo.ruano@miami.edu
Rodrigo Ruano
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).
- Conditions
- Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction, Bladder Outflow Obstruction
- Being tested
- Fetoscopes, Fetal Cystoscopy
- Medical subject headings
- Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FetoscopesDevice
Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.
Fetal CystoscopyProcedure or surgery
A fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Cystoscopy Group | Experimental | Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation. Receives: Device: Fetoscopes; Procedure: Fetal Cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants where the procedure was technically performed
Number of participants where the fetal cystoscopy procedure was successfully technically performed.
Measured: Day 1 (Post fetal cystoscopy procedure)
Number of participants where the etiology of LUTO was correctly diagnosed
Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy
Measured: Up to 1 month post delivery
Number of participants where the posterior urethral valve were successfully released
Number of participants where the posterior urethral valve were successfully released
Measured: Day 1 (Post fetal cystoscopy procedure)
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia
As per treating physician evaluation of clinical assessments post-natal.
Measured: Up to 1 month post delivery
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment
As per treating physician evaluation of clinical assessments post-natal.
Measured: Up to 24 months post delivery
Number of participants whose fetal cystoscopy resulted in maternal complications
Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth <37 weeks), extremely preterm birth (<32 weeks), and urological fistulae and fetal demise.
Measured: Day 1 post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Jan 2018
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Obstructive SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Ruano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Ruano, University of Miami
- Investigators
- Rodrigo Ruano, MD, PhD., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281798
- Sponsor's protocol ID
- 20220117-1
- Other IDs
- 16-008556
- Acronym
- CYSTO
- Status last verified
- Feb 2026
- First submitted
- 11 Sep 2017
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
- ClinicalTrials.gov ID
- NCT03281798
- Acronym / sponsor ID
- CYSTO / 20220117-1
- Conditions
- Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction, Bladder Outflow Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rodrigo RuanoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 13 Sep 2017 (actual)
- 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.
The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Cystoscopy Group | Experimental | Device: Fetoscopes, Procedure: Fetal CystoscopyParticipants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pregnant women
- Singleton pregnancy
- Maternal age ≥ 18 years
- Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
- Oligohydramnios or Anhydramnios
Key exclusion criteria (15 listed)
- Fetal anomaly unrelated to LUTO
- Congenital cardiac anomaly
- Female fetus
- Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
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 |
|---|---|---|
| FetoscopesFetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen. | Device | Fetal Cystoscopy Group |
| Fetal CystoscopyA fetoscope will be inserted into the fetal bladder via the maternal abdomen and advanced into the fetal bladder outlet. Identified obstruction will be opened using laser. | Procedure or surgery | Fetal Cystoscopy Group |
Primary outcome
Number of participants where the procedure was technically performed
Time frame: Day 1 (Post fetal cystoscopy procedure)
Number of participants where the fetal cystoscopy procedure was successfully technically performed.
Number of participants where the etiology of LUTO was correctly diagnosed
Time frame: Up to 1 month post delivery
Number of participants where the etiology of LUTO was correctly diagnosed during fetal cystoscopy as compared to post natal cystoscopy
Number of participants where the posterior urethral valve were successfully released
Time frame: Day 1 (Post fetal cystoscopy procedure)
Number of participants where the posterior urethral valve were successfully released
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia
Time frame: Up to 1 month post delivery
As per treating physician evaluation of clinical assessments post-natal.
Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment
Time frame: Up to 24 months post delivery
As per treating physician evaluation of clinical assessments post-natal.
Number of participants whose fetal cystoscopy resulted in maternal complications
Time frame: Day 1 post delivery
Maternal and obstetrical complications such as preterm premature rupture of the membranes (PPROM), prematurity (birth <37 weeks), extremely preterm birth (<32 weeks), and urological fistulae and fetal demise.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Rodrigo Ruano, MD, PhD. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopes and Fetal Cystoscopy in people with Lower Urinary Tract Obstructive Syndrome and Lower Urinary Tract Obstruction, Congenital, run by Rodrigo Ruano at 2 sites 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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo A Ruano, MD, PhD. (305.243.0769, rodrigo.ruano@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants where the procedure was technically performed (time frame: Day 1 (Post fetal cystoscopy procedure)). The study lists 6 primary outcomes in all. 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 24 Feb 2026.