ClinicalTrials.gg
Sign In
RecruitingNCT03281798CYSTOUpdated Feb 24, 2026

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

An interventional study of Fetoscopes and Fetal Cystoscopy in Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital and Bladder Outlet Obstruction, sponsored by Rodrigo Ruano. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Rodrigo Ruano · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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).

02

Conditions studied

  • Lower Urinary Tract Obstructive Syndrome
  • Lower Urinary Tract Obstruction, Congenital
  • Bladder Outlet Obstruction
  • Bladder Outflow Obstruction
03

In context

Urinary Bladder Neck Obstruction

46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.

This study's planned enrollment of 10 is below the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.

Browse Urinary Bladder Neck Obstruction studies →

Lead sponsor

Rodrigo Ruano is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Pregnant women
  2. Singleton pregnancy
  3. Maternal age ≥ 18 years
  4. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
  5. Oligohydramnios or Anhydramnios
  6. 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).
  7. Absence of chromosomal abnormalities and associated anomalies
  8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
  9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
  10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
  11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
  12. Parents or guardian are willing to provide signed .

Exclusion criteria

Exclusion Criteria:

  1. Fetal anomaly unrelated to LUTO
  2. Congenital cardiac anomaly
  3. Female fetus
  4. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
  5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
  6. to surgery including previous hysterotomy in active uterine segment
  7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
  8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
  9. Maternal , 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
  10. Maternal medical condition that is a contraindication to surgery or anesthesia
  11. 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.
  12. Inability to comply with travel and follow-up requirements of the trial
  13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
  14. Patients declining invasive testing
  15. Family does not meet psychosocial criteria including insufficient
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Fetal Cystoscopy Group

    Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.

    Device: Fetoscopes · Procedure: Fetal Cystoscopy

Interventions

  • DeviceFetoscopes

    Fetoscopes are telescopes developed for procedures involving fetal interventions and is inserted through the maternal abdomen.

  • ProcedureFetal Cystoscopy

    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.

06

What researchers measure

Primary outcomes

  1. Number of participants where the procedure was technically performed

    Number of participants where the fetal cystoscopy procedure was successfully technically performed.

    Time frame: Day 1 (Post fetal cystoscopy procedure)

  2. 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

    Time frame: Up to 1 month post delivery

  3. Number of participants where the posterior urethral valve were successfully released

    Number of participants where the posterior urethral valve were successfully released

    Time frame: Day 1 (Post fetal cystoscopy procedure)

  4. 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.

    Time frame: Up to 1 month post delivery

  5. 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.

    Time frame: Up to 24 months post delivery

  6. 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.

    Time frame: Day 1 post delivery

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Aug 2028, 127 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 13, 2017
StartActual
Jan 1, 2018
Primary completionEst.
Aug 1, 2028
CompletionEst.
Aug 1, 2028
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03281798
Lead sponsor
Rodrigo Ruano
Responsible party
Rodrigo Ruano (Professor, University of Miami) — Sponsor-investigator
First posted
Sep 13, 2017
Start date
Jan 1, 2018
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Feb 24, 2026

Study contacts

Rodrigo A Ruano, MD, PhD.
Contact
rodrigo.ruano@miami.edu
305.243.0769
Rodrigo Ruano, MD, PhD.
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Bladder Neck Obstruction →

Other studies from this sponsor

Rodrigo Ruano

Start the discussion