Lower Urinary Tract Obstruction, Congenital
Conditions
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.
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.
Interventions
DEVICEFetal 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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra | 24 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 balloon | 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. |
| Number of procedures that achieved technical success of valvuloplasty | 24 months | Technical success of valvuloplasty is defined as passage of balloon during dilation of valve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amniotic fluid volume after the procedure (major vertical pocket) | 24 hours after procedure | Amniotic fluid volume is reported based on ultrasound measurements of Maximum Vertical Pocket (MVP), and is reported in centimeters (cm) |
| Fetal lung growth after treatment | Baseline | Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference |
| Number of fetuses to experience complications | 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 |
| Number of mothers to experience complications | 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. |
| Gestational age at delivery | Gestational age at delivery, up to 9 months | Gestational age at time of delivery, reported in weeks |
| Renal changes after treatment | 24 months | Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis |
| Survival rate | 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 |
| Serum creatinine level | 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age | Serum creatinine level will be measured by blood test |
| Need for dialysis | 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age | Number of neonates to require dialysis |
| Grading of oxygen dependency | 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 |
| Occurrence of severe pulmonary hypertension | Baseline | Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization. |
| Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up | 24 months | Number of neonates to require ECMO support at any point during the first 24 months |
| Days in neonatal intensive care unit during the first hospitalization | During first hospitalization (assessed up to 10 days) | Total number of days in neonatal intensive care unit during the first hospitalization |
| Ventilator support during the first hospitalization | During first hospitalization (assessed up to 10 days) | Total number of days of ventilator support during the first hospitalization |
| Presence of neonatal sepsis | Baseline | Total number of neonates to experience neonatal sepsis, defined as intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher). |
| Total number of patients to require surgery | Baseline | Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure |
| Days of maternal hospitalization. | Two weeks from day of admission | Total number of days in hospital after giving birth |
| Operative times | During procedure | Length of time to complete fetal cystoscopy, reported in minutes |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMauro H. Schenone, M.D.
Mayo Clinic
Outcome results
None listed