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Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)

22 juli 2026 bijgewerkt door: Mauro H. Schenone, Mayo Clinic
The purpose of this research is to determine the feasibility and safety of performing fetal operative cystoscopy for the treatment of Lower Urinary Tract Obstruction (LUTO) using investigational devices.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Fetal cystoscopy involves the use of a tiny camera to find the cause of the urinary tract blockage and to treat it at the same time. When a fetus is found to have LUTO, this means there is a blockage in the urethra (tube that passes urine from the bladder to outside the body) which leads to kidney, lung, and other organ damage in the fetus.

Fetal surgery is when the unborn baby is in the mother's uterus (in utero). This study will see if certain investigational devices are safe for the fetal cystoscopy procedure.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 18 years of age or older
  • Pregnant women carrying a singleton gestation and male fetus
  • Able to perform the procedure at a gestational age between 16 0/7 and 25 6/7 weeks of gestation
  • Lower urinary tract obstruction: Enlarged bladder (subjectively assessed), keyhole sign, bladder wall thickening (subjectively assessed), and bilateral hydro (uretero) nephrosis.27
  • Absence of chromosomal abnormalities and other anomalies unrelated to the urinary tract obstruction.
  • Oligo or anhydramnios at or after 16 weeks of gestation
  • Evidence of conserved renal function (a Nassr et al., score of 3 or less ).
  • Able to understand the requirements of the study, and willing and able to consent for enrollment in the study

Exclusion Criteria:

  • Severe maternal health condition precluding procedure.

    • Increased risk for preterm labor including short cervical length, 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 (at or above the level of the round ligaments).
    • 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 o
  • Female fetus
  • Significant pathogenic or likely pathogenic finding on karyotype or microarray
  • Significant unrelated fetal anomaly, as opposed to a nonsignificant one that would not preclude enrollment.
  • Multiple gestation
  • Technical limitations precluding the procedure, such as, no fetoscopic approach due to placental position or fetal position.
  • Inability to comply with travel and follow-up requirements of the trial

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Toestel Haalbaarheid
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
Apparaat: Fetal cystoscope

The fetoscope assembly includes the the Boston Scientific Maverick 2 balloon catheter and Emerge balloon, the Karl Storz Miniature Straight Forward Telescope, Operating Sheath, and connector.

A fetal cystoscopy will be performed for treatment of lower urinary tract obstruction complicated by oligo/anhydramnios.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Tijdsspanne: 24 months
Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
24 months
Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Tijdsspanne: 24 months
Technical success of posterior urethral valve ablation with laser to allow passage of balloon is defined as completing urethral valve ablation during the procedure.
24 months
Number of procedures that achieved technical success of valvuloplasty
Tijdsspanne: 24 months
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
24 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Amniotic fluid volume after the procedure (major vertical pocket)
Tijdsspanne: 24 hours after procedure
Amniotic fluid volume is reported based on ultrasound measurements of Maximum Vertical Pocket (MVP), and is reported in centimeters (cm)
24 hours after procedure
Fetal lung growth after treatment
Tijdsspanne: Baseline
Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference
Baseline
Number of fetuses to experience complications
Tijdsspanne: Baseline
Fetal safety will be assessed as number of fetuses to experience complications, defined as premature delivery, prelabor rupture of membranes, injury to the fetus, abdominal hernia, vesicoamniotic or vesicoperitoneal fistula, chorioamniotic separation, fetal bleeding, bradycardia, fetal anemia, brain injury, or death
Baseline
Number of mothers to experience complications
Tijdsspanne: Baseline
Maternal safety will be assessed as number of mothers to experience complications, defined as wound infection, chorioamnionitis, bleeding, injury to surrounding organs, amniotic fluid leak, prelabor rupture of membranes, placental abruption, preterm delivery, pseudomembranous colitis, mirror syndrome/preeclampsia, or death.
Baseline
Gestational age at delivery
Tijdsspanne: Gestational age at delivery, up to 9 months
Gestational age at time of delivery, reported in weeks
Gestational age at delivery, up to 9 months
Renal changes after treatment
Tijdsspanne: 24 months
Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis
24 months
Survival rate
Tijdsspanne: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Survival of neonates at post natal follow up points of 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Serum creatinine level
Tijdsspanne: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Serum creatinine level will be measured by blood test
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Need for dialysis
Tijdsspanne: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Number of neonates to require dialysis
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Grading of oxygen dependency
Tijdsspanne: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Grading of oxygen dependency is categorized as: none, mild, moderate, or severe
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Occurrence of severe pulmonary hypertension
Tijdsspanne: Baseline
Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
Baseline
Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Tijdsspanne: 24 months
Number of neonates to require ECMO support at any point during the first 24 months
24 months
Days in neonatal intensive care unit during the first hospitalization
Tijdsspanne: During first hospitalization (assessed up to 10 days)
Total number of days in neonatal intensive care unit during the first hospitalization
During first hospitalization (assessed up to 10 days)
Ventilator support during the first hospitalization
Tijdsspanne: During first hospitalization (assessed up to 10 days)
Total number of days of ventilator support during the first hospitalization
During first hospitalization (assessed up to 10 days)
Presence of neonatal sepsis
Tijdsspanne: Baseline
Total number of neonates to experience neonatal sepsis, defined as intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher).
Baseline
Total number of patients to require surgery
Tijdsspanne: Baseline
Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure
Baseline
Days of maternal hospitalization.
Tijdsspanne: Two weeks from day of admission
Total number of days in hospital after giving birth
Two weeks from day of admission
Operative times
Tijdsspanne: During procedure
Length of time to complete fetal cystoscopy, reported in minutes
During procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mayo Clinic

Onderzoekers

  • Hoofdonderzoeker: Mauro H. Schenone, M.D., Mayo Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 mei 2026

Primaire voltooiing (Geschat)

23 maart 2056

Studie voltooiing (Geschat)

23 maart 2060

Studieregistratiedata

Eerst ingediend

16 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 23-008546

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

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