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Fetal Cystoscopy for Lower Urinary Tract Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02446184
Recruitment Status : Terminated (Original P.I. of this study transferred to a different institution.)
First Posted : May 18, 2015
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Belfort, Baylor College of Medicine

Brief Summary:
This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to the investigators clinical experience with fetal vesicoamniotic shunting.

Condition or disease Intervention/treatment Phase
Urethral Obstruction Procedure: Fetal Cystoscopy Procedure: Fetal vesicoamniotic shunt Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This study is an un-blinded, non-randomized, single arm Phase 1 study. Fetal intervention is usually offered to patients carrying fetuses with isolated LUTO that meet the inclusion criteria. Once the patient elected to have fetal intervention, fetal cystoscopy will be offered as an experimental procedure as an option to fetal vesico-amniotic shunting.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction - a Prospective Trial
Actual Study Start Date : December 4, 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 23, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fetal cystoscopy
Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.
Procedure: Fetal Cystoscopy
Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.

Active Comparator: Vesicoamniotic shunt
The fetal vesicoamniotic shunt is considered the standard prenatal therapy for severe LUTO. Amnioinfusion and vesicoamniotic shunt placement will be performed under ultrasound guidance.
Procedure: Fetal vesicoamniotic shunt
Fetal vesicoamniotic shunt will be performed under ultrasound guidance
Other Name: Bladder shunt

No Intervention: No fetal intervention group
Those patients that refuse fetal intervention and do not elect to terminate the pregnancy will be followed as part of the no fetal intervention group.



Primary Outcome Measures :
  1. Postnatal survival at 2 years of life [ Time Frame: 2 years ]
    We will evaluate the survival rate at 2 years of life


Secondary Outcome Measures :
  1. Postnatal renal function at 2 years of life [ Time Frame: 2 years ]
    We will evaluate the renal function at 2 years of life based on the glomerular filtration rate (GFR). In addition, we will evaluate the need for dialysis and renal transplant.



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Ages Eligible for Study:   16 Weeks to 26 Weeks   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
  • Oligohydramnios or Anhydramnios after 18 weeks
  • "Favorable urine analysis after 18 weeks (urinary sodium is < 100mEq/L, chloride < 90mEq/L, osmolarity <200mOsm/L and β2-microglobulin <6mg/L 7)
  • Absence of chromosomal abnormalities and associated anomalies (Normal karyotype by invasive testing (amniocentesis or CVS))
  • Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks

Exclusion Criteria:

  • Fetal anomaly unrelated to LUTO
  • Congenital cardiac anomaly
  • 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 - A body-mass index ≥ 35
  • 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 a support person (ie. Spouse, partner, mother) available to support the patient for the duration of the pregnancy at Texas Children's Hospital/Ronald McDonald House
  • Patient does not have healthy insurance to cover routine clinical care at Texas Children's Hospital 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 the 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446184


Locations
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United States, Texas
Texas Children's Hospital Pavilion for Women
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Michael A Belfort, MD, PhD Baylor College of Medicine
Principal Investigator: Rodrigo Ruano, MD, PhD Baylor Colleg of Medicine (Previously); Mayo Clinic (currently)

Publications of Results:

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Responsible Party: Michael Belfort, MD PhD, Professor Baylor College of Medicine and Co-Director Texas Children's Fetal Center, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02446184     History of Changes
Other Study ID Numbers: BCM H33626
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Belfort, Baylor College of Medicine:
urethral obstruction
posterior urethral valves
lower urinary tract obstruction

Additional relevant MeSH terms:
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Urethral Obstruction
Urethral Diseases
Urologic Diseases