Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction - a Prospective Trial

Patients with severe LUTO will come for clinical evaluation as part of the standard clinical care at the Fetal Center at Texas Children's Hospital. Once the diagnosis of fetal severe LUTO is confirmed and the patient is considered for fetal intervention, patient will be invited to participate in the present study. Fetal cystoscopy will be offered as an optional experimental procedure.

The following information will be obtained in the standard clinical care visit as usual: a. demographics (maternal age, parity); b. gestational age at the diagnosis of LUTO; c. fetal ultrasound findings including documentation of cervical length, gestational age,fetal bladder size, bladder wall thickness, degree of fetal hydronephrosis, amount of amniotic fluid, fetal biometry; d. fetal urinary biochemistry; e. fetal echocardiogram findings.

The standard management options for fetal LUTO include expectant management, fetal vesico-amniotic shunting or termination of pregnancy according to the law. These options will be offered to all patients as the first set of management options and the gold standard. In addition, the investigators group will offer the procedure as an alternative experimental option, with a full explanation of the experimental nature of the procedure, the technical benefits and difficulties, and the risks and potential benefits of the procedure and the limited long-term outcomes information. Those patients who request participation in the present study will be informed that they can, a priori, select a crossover arm if for any reason the fetal cystoscopic procedure is not possible. They can elect that a fetal vesico-amniotic shunting be performed or prenatal expectant management or even termination of pregnancy (as part of the standard management of fetuses with LUTO).

Participation in the study:

Once the patient is deemed eligible, all prenatal standard management options will be offered first to the patient. Fetal cystoscopy will be offered as an investigational procedure for evaluation. If the patient opts for the fetal cystoscopy, we will explain that this procedure can be diagnostic and therapeutic. In order to prevent coercion, the investigation procedure will be presented to the patient in a manner that is an option and voluntary, if the patient chooses not to participate in the investigational procedure, the clinical care will not be affected. Informed consent to participate in the present study will be obtained. We will also include non-English speaking subjects in the present study. We will submit a full Spanish consent via amendment for IRB approval after approval of the English consent. We will not enroll any non-English subjects until we receive final approval. The study flow is demonstrated in Figure 1 (see attached document).