Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
22 juli 2026 uppdaterad av: Mauro H. Schenone, Mayo Clinic
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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
10
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Fetal operative cystoscopy
Patients pregnant with a male baby who has a lower urinary tract obstruction
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Tidsram: 24 months
|
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
Tidsram: 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.
|
24 months
|
|
Number of procedures that achieved technical success of valvuloplasty
Tidsram: 24 months
|
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
|
24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Amniotic fluid volume after the procedure (major vertical pocket)
Tidsram: 24 hours after procedure
|
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
Tidsram: Baseline
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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
Tidsram: 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
|
Baseline
|
|
Number of mothers to experience complications
Tidsram: 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.
|
Baseline
|
|
Gestational age at delivery
Tidsram: Gestational age at delivery, up to 9 months
|
Gestational age at time of delivery, reported in weeks
|
Gestational age at delivery, up to 9 months
|
|
Renal changes after treatment
Tidsram: 24 months
|
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
Tidsram: 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
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Serum creatinine level
Tidsram: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
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
Tidsram: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
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
Tidsram: 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
|
28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
|
|
Occurrence of severe pulmonary hypertension
Tidsram: Baseline
|
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
Tidsram: 24 months
|
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
Tidsram: During first hospitalization (assessed up to 10 days)
|
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
Tidsram: During first hospitalization (assessed up to 10 days)
|
Total number of days of ventilator support during the first hospitalization
|
During first hospitalization (assessed up to 10 days)
|
|
Presence of neonatal sepsis
Tidsram: Baseline
|
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
Tidsram: Baseline
|
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.
Tidsram: Two weeks from day of admission
|
Total number of days in hospital after giving birth
|
Two weeks from day of admission
|
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Operative times
Tidsram: During procedure
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Length of time to complete fetal cystoscopy, reported in minutes
|
During procedure
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Samarbetspartners och utredare
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Sponsor
Utredare
- Huvudutredare: Mauro H. Schenone, M.D., Mayo Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 maj 2026
Primärt slutförande (Beräknad)
23 mars 2056
Avslutad studie (Beräknad)
23 mars 2060
Studieregistreringsdatum
Först inskickad
16 mars 2026
Först inskickad som uppfyllde QC-kriterierna
4 maj 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 23-008546
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