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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

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

Who can participate

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

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 informed consent.

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. Contraindications 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 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
  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
04

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.

05

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

06

Study locations

1 of 2 sites recruiting
  • University of Miami
    Miami, Florida 33136, United States
    • Rodrigo Ruano, MD, Ph.D · Contact · rodrigo.ruano@miami.edu · 305-243-0769
    • Rodrigo Ruano · Principal investigator
    Recruiting
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
    Terminated
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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