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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lower Urinary Tract Obstruction, Congenital
• Intervention / Treatment: Device: Fetal cystoscope

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fetal operative cystoscopy; Patients pregnant with a male baby who has a lower urinary tract obstruction	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra	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	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	Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amniotic fluid volume after the procedure (major vertical pocket)	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	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	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	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	Gestational age at time of delivery, reported in weeks	Gestational age at delivery, up to 9 months
Renal changes after treatment	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	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	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	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	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	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	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	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	Total number of days of ventilator support during the first hospitalization	During first hospitalization (assessed up to 10 days)
Presence of neonatal sepsis	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	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.	Total number of days in hospital after giving birth	Two weeks from day of admission
Operative times	Length of time to complete fetal cystoscopy, reported in minutes	During procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mauro H. Schenone, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 23, 2056
• Study Completion (Estimated): March 23, 2060

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-008546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes