What side effects are associated with this type of intervention?

Common treatments for Bladder Outlet Obstruction (BOO) include catheterization, medications like alpha-blockers (e.g., alfuzosin), and surgical interventions. For fetal LUTO, interventions such as vesico-amniotic shunting are used. Side effects of catheterization can include urinary tract infections and discomfort. Alpha-blockers may cause dizziness, fatigue, and hypotension. Surgical interventions can lead to complications such as infection, bleeding, and injury to surrounding tissues. Vesico-amniotic shunting in fetuses carries risks like preterm labor, infection, and shunt displacement.

What prior FDA approvals exist?

The FDA has approved several treatments for Bladder Outlet Obstruction (BOO), primarily targeting conditions like benign prostatic hyperplasia (BPH) in adults. Commonly approved medications include alpha-1-adrenergic antagonists (e.g., tamsulosin, alfuzosin) and 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), which help reduce symptoms by relaxing the bladder neck muscles and shrinking the prostate, respectively. For severe cases, surgical options like transurethral resection of the prostate (TURP) are also approved. While specific FDA-approved treatments for fetal lower urinary tract obstruction (LUTO) are not detailed, the principles of relieving obstruction and ensuring proper urinary flow are central to both adult and fetal interventions.

What other types of research exist?

As of 2024, promising novel alternatives to fetal intervention for LUTO in bladder outlet obstruction patients include advancements in minimally invasive procedures such as percutaneous vesicoamniotic shunting and the use of fetal cystoscopy with laser ablation. These techniques aim to relieve obstruction while minimizing risks associated with more invasive fetal surgeries. Additionally, ongoing research into gene therapy and regenerative medicine may offer future potential treatments.

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Fetoscopy

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

N/A

Waitlist Available

Led By Rodrigo Ruano, MD

Research Sponsored by Rodrigo Ruano

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male fetus with LUTO, dilated bladder, 'keyhole sign' and bilateral hydronephrosis

Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy)

Must not have

Female fetus

Contraindications to surgery including previous hysterotomy in active uterine segment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the outcomes of medical procedures on unborn babies to treat serious urinary blockages. It focuses on pregnant women and their fetuses with severe urinary tract obstructions. The treatment aims to clear the blockage, allowing normal urine flow and aiding in fetal development.

Who is the study for?

This trial is for pregnant women over 18 with a male fetus diagnosed with severe LUTO, between 16 and nearly 26 weeks gestation. The fetus must have no chromosomal abnormalities or unrelated anomalies, and the mother should have favorable urine analysis results without prior in utero interventions. Women must not be at increased risk of preterm labor or have conditions that complicate surgery.

What is being tested?

The study tests fetal cystoscopy outcomes on mothers and fetuses facing severe isolated LUTO at University of Miami/Jackson Health System. It involves using tiny instruments to view and potentially treat urinary blockages in the fetus during pregnancy.

What are the potential side effects?

While specific side effects are not listed, fetal surgeries like cystoscopies can carry risks such as preterm labor, rupture of membranes, infection risks for both mother and child, bleeding complications, or potential harm to the fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My male fetus has a blocked urinary tract, swollen bladder, keyhole sign, and kidney swelling.

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My recent urine tests show low levels of sodium, chloride, and osmolality without any prior fetal treatments.

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My genetic tests show no chromosomal abnormalities.

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My karyotype is normal based on amniocentesis or CVS results.

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My family and I decided against ending the pregnancy before 24 weeks.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am carrying a female fetus.

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I cannot have surgery due to a previous cut in my uterus.

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I was born with a heart defect.

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I cannot follow the trial's travel and follow-up schedule.

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I cannot have fetoscopic surgery due to conditions like uterine fibroids or anomalies.

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I have a health condition that makes surgery or anesthesia unsafe for me.

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My unborn baby has a condition not related to lower urinary tract obstruction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants where the etiology of LUTO was correctly diagnosed

Number of participants where the posterior urethral valve were successfully released

Number of participants where the procedure was technically performed

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fetal Cystoscopy GroupExperimental Treatment2 Interventions

Participants in this group will receive the fetal cystoscopy procedure around 16 weeks 0 days to 25 weeks and 6 days of gestation.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bladder Outlet Obstruction (BOO) include alpha-1-adrenergic antagonists, 5-alpha reductase inhibitors, and surgical interventions like transurethral resection of the prostate (TURP). Alpha-1-adrenergic antagonists work by relaxing the smooth muscle in the bladder neck and prostate, improving urine flow. 5-alpha reductase inhibitors reduce the size of the prostate by inhibiting the conversion of testosterone to dihydrotestosterone. Surgical interventions like TURP physically remove the obstructive tissue. These treatments are crucial for BOO patients as they alleviate symptoms, prevent complications like urinary retention, and improve quality of life. In the context of fetal intervention for LUTO, relieving the obstruction is vital to prevent severe complications such as kidney damage and impaired lung development.