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

N/AEnrolling By InvitationNCT07572227

Mayo Clinic10 enrolled

Overview

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.

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Lower Urinary Tract Obstruction, Congenital

Interventions

Fetal cystoscopeDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 24 months

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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