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Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO) (LUTO)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281798
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Rodrigo Ruano M.D., Ph.D, Mayo Clinic

Brief Summary:

This is a pilot study to evaluate the safety, feasibility and effectiveness of fetal cystoscopy in the prenatal diagnosis and therapy of fetuses with bladder outlet obstruction. Fetal bladder outlet obstruction is a rare congenital anomaly with severe consequences to the fetus. Because of the bladder outlet obstruction, amniotic fluid is diminished, drastically leading to abnormal development of the fetal lungs. In addition, the obstruction leads to significant kidney damage, including development of end stage renal disease. Fetal vesicoamniotic shunting is the clinical therapeutic option for these fetuses. However, the shunt has many complications including blockage and dislodgement. Fetal cystoscopy has been proposed as an alternative treatment with potential advantages over the shunt by allowing the correct prenatal diagnosis and specific treatment. Initial clinical trials have demonstrated favorable outcomes.

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) at Mayo Clinic in Rochester, Minnesota. The objectives are 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 our clinical experience with fetal vesico-amniotic shunting.


Condition or disease Intervention/treatment Phase
Congenital Disorders Bilateral Hydronephrosis Lower Urinary Tract Obstructive Syndrome Device: Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Fetuses with LUTO
Performance of ultrasound-guided, percutaneous fetal cystoscopy with the Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set
Device: Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set
2.0 mm fetoscopy or flexible ureteroscope




Primary Outcome Measures :
  1. Number of successfully completed surgical procedures [ Time Frame: Four hours following start of surgical procedure ]
    Performance of percutaneous fetal cystoscopy with ultrasound-fetoscopic guidance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females of child-bearing age
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant females age ≥ 18 years
  • Oligohydramnios or Anhydramnios
  • Singleton male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
  • Urine analysis: urinary sodium < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, osmolarity <200 milliosmoles/liter (mOsm/L) and β2-microglobulin <6mg/L
  • Absence of chromosomal abnormalities and associated anomalies
  • Gestational age at the time of the procedure between 16 0/7 weeks and 25 6/7 weeks
  • Normal karyotype by invasive testing (amniocentesis or CVS).
  • Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
  • Family has sufficient social support and ability to understand requirements of the study.
  • Parents or guardians are willing to provide signed informed consent.

Exclusion Criteria:

  • Fetal anomaly or congenital cardiac anomaly unrelated to LUTO
  • Female fetus
  • Increased risk for preterm labor, cervical length (<1.5 cm), previous preterm birth, history of incompetent cervix with or without cerclage
  • 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 positive (testing must be done and be negative)
  • Maternal medical condition that is a contraindication to surgery or anesthesia
  • Patient does not have health insurance to cover routine prenatal clinical care, including prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting
  • 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
  • Unable to understand the study procedures or unable to provide voluntary informed consent

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): NCT03281798


Contacts
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Contact: Shonie L Buenvenida, BSN, RN 507-255-8752 buenvenida.shonie@mayo.edu
Contact: Maureen A Lemens, BSN, RN 507-293-1487 lemens.maureen@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Rodrigo Ruano, MD PhD    507-284-0210    ruano.rodrigo@mayo.edu   
Contact: Maureen Lemens, RN    507-775-3809    Lemens.Maureen@mayo.edu   
Sponsors and Collaborators
Rodrigo Ruano M.D., Ph.D
Investigators
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Principal Investigator: Rodrigo Ruano, M.D., Ph.D. Mayo Clinic
Additional Information:
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Responsible Party: Rodrigo Ruano M.D., Ph.D, Professor of Obstetrics and Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03281798    
Other Study ID Numbers: 16-008556
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Hydronephrosis
Kidney Diseases
Urologic Diseases