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Recruiting NCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

No phase Interventional Lower Urinary Tract Obstructive Syndrome Lower Urinary Tract Obstruction, Congenital Bladder Outlet Obstruction Bladder Outflow Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fetoscopes, Fetal Cystoscopy.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction, Bladder Outflow Obstruction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial

Overview

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).

Interventions

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

Primary outcome measures

  • Number of participants where the procedure was technically performed [Time frame: Day 1 (Post fetal cystoscopy procedure)]
  • Number of participants where the etiology of LUTO was correctly diagnosed [Time frame: Up to 1 month post delivery]
  • Number of participants where the posterior urethral valve were successfully released [Time frame: Day 1 (Post fetal cystoscopy procedure)]
  • Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe pulmonary hypoplasia [Time frame: Up to 1 month post delivery]
  • Number of participants whose fetal cystoscopy resulted in the prevention of post-natal severe renal impairment [Time frame: Up to 24 months post delivery]
  • Number of participants whose fetal cystoscopy resulted in maternal complications [Time frame: Day 1 post delivery]

Eligibility criteria

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Miami — Miami
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT03281798 · 20220117-1 · 16-008556

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗