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

NCT07572227 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 23-008546
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Urinary Tract Obstruction, Congenital

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (18)

• Amniotic fluid volume after the procedure (major vertical pocket)

  24 hours after procedure

• Fetal lung growth after treatment

  Baseline

• Number of fetuses to experience complications

  Baseline

• Number of mothers to experience complications

  Baseline

• Gestational age at delivery

  Gestational age at delivery, up to 9 months

Study Arms (1)

Fetal operative cystoscopy

EXPERIMENTAL

Patients pregnant with a male baby who has a lower urinary tract obstruction

Device: Fetal cystoscope

Interventions

Fetal cystoscope DEVICE

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.

Fetal operative cystoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Mauro H. Schenone, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 10 pregnant women carrying a singleton gestation and male fetus with lower urinary tract obstruction will be enrolled as subjects. Mothers and babies will be followed for 24 months post delivery for outcomes.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 23, 2056
• Study Completion (Estimated): March 23, 2060
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)