Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO) (NCT07572227) | Clinical Trial Compass
By InvitationNot Applicable
Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
United States10 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Sign…
What they're measuring
1
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Timeframe: 24 months
2
Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Timeframe: 24 months
3
Number of procedures that achieved technical success of valvuloplasty