Back to search results
NCT07572227

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

Enrolling by Invitation
NAAges 18+InterventionalDevice feasibility
Mayo Clinic
~10 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Fetal cystoscope

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Measured over 24 months
+2 more outcomes measured

Conditions

Lower Urinary Tract Obstruction, Congenital

Explore related trials

Fetal lower urinary tract obstruction

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Mauro H. Schenone, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra24 months

    Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.

  • Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon24 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.

  • Number of procedures that achieved technical success of valvuloplasty24 months

    Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.