Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

Overseen By Rodrigo Ruano, MD, Ph.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Rodrigo Ruano

Disqualifiers: Fetal anomaly, Cardiac anomaly, Female fetus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how fetal cystoscopy, a procedure to examine a baby's bladder, can assist with severe Lower Urinary Tract Obstruction (LUTO) in unborn babies. The goal is to understand the impact of this intervention on both the mother and the fetus. The trial seeks pregnant women carrying a male fetus diagnosed with severe LUTO, characterized by a very full bladder and certain kidney issues. Participants should not have other unrelated fetal anomalies or serious maternal health issues that might affect surgery. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve outcomes for future pregnancies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that fetal cystoscopy is safe for fetal intervention?

Research has shown that fetal cystoscopy is a challenging yet crucial procedure for treating severe lower urinary tract blockage in unborn babies. This procedure is primarily considered when the baby's kidney function remains good. Studies have examined its safety and practicality, indicating that it can help prevent death around the time of birth.

As a pilot study, fetal cystoscopy remains in the early stages of testing. While initial results appear promising, there may be limited information on long-term safety. However, its ongoing testing suggests it is safe enough for researchers to continue studying. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fetal cystoscopy for severe lower urinary tract obstruction because it offers a new approach by directly addressing the blockage in the fetus. Unlike traditional treatments that might focus on managing symptoms after birth, this procedure aims to intervene early during pregnancy, potentially preventing complications before they develop. By using a tiny camera to visualize and relieve the obstruction in the fetus, fetal cystoscopy could improve outcomes for both the baby and the mother, offering hope for a more proactive solution to a challenging condition.

What evidence suggests that fetal cystoscopy is effective for severe lower urinary tract obstruction?

Research has shown that fetal cystoscopy, the procedure under study in this trial, can assist with severe lower urinary tract obstruction (LUTO) when the baby's kidneys function well. This procedure aims to clear the urinary tract blockage, which is crucial for preventing kidney damage. Studies have found that fetal cystoscopy might help prevent death around the time of birth by improving the fluid around the baby and reducing pressure on the developing urinary system. Although challenging, early evidence suggests it can be a promising option for severe LUTO cases. ^{1 2 3 5 6}

Who Is on the Research Team?

Rodrigo Ruano, MD, Ph.D

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks

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

Exclusion Criteria

I am carrying a female fetus.

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

I choose not to undergo invasive tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetal Cystoscopy Procedure

Participants undergo fetal cystoscopy procedure between 16 weeks 0 days to 25 weeks and 6 days of gestation

1 day

1 visit (in-person)

Post-Procedure Monitoring

Participants are monitored for immediate outcomes and complications post-procedure

1 day

Follow-up

Participants are monitored for safety and effectiveness after delivery, including prevention of severe pulmonary hypoplasia and renal impairment

Up to 24 months post delivery

What Are the Treatments Tested in This Trial?

Interventions

• Fetal Cystoscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: Fetal Cystoscopy Group Experimental Treatment 2 Interventions

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

Fetal Cystoscopy is already approved in European Union, United States for the following indications:

Approved in European Union as Fetal Cystoscopy for:

• Severe Lower Urinary Tract Obstruction (LUTO)

Approved in United States as Fetal Cystoscopy for:

• Severe Lower Urinary Tract Obstruction (LUTO)

Who Is Running the Clinical Trial?

Rodrigo Ruano

Lead Sponsor

Trials

5

Recruited

40+

Published Research Related to This Trial

A successful case of percutaneous fetal cystoscopy was performed on a male fetus at 19 weeks of gestation, confirming the diagnosis of posterior urethral valves and allowing for therapeutic intervention at 22 weeks.

This case demonstrates the potential of fetal cystoscopy as a feasible method for diagnosing and treating congenital urinary tract anomalies, although further studies are necessary to evaluate its overall effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous fetal cystoscopy and endoscopic fulguration of posterior urethral valves. Quintero, RA., Hume, R., Smith, C., et al.[2019]

Fetal cystoscopy can change the ultrasound diagnosis of congenital lower urinary tract obstruction in a significant percentage of cases, with alterations noted in 36.4% and 25.0% of fetuses in two studies.

While fetal cystoscopy showed a high odds ratio for improved perinatal survival compared to no treatment (20.51), it did not demonstrate a significant advantage over vesicoamniotic shunt, indicating that its effectiveness as a therapeutic intervention remains uncertain and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Morris, RK., Ruano, R., Kilby, MD.[2022]

Fetal cystoscopy and vesicoamniotic shunting significantly improve the 6-month survival rate in fetuses with severe lower urinary obstruction (LUTO), with adjusted relative risks of 1.86 and 1.73 respectively compared to no intervention.

Fetal cystoscopy is particularly effective in preserving normal renal function in cases of posterior urethral valves, showing a significant improvement in both survival and renal function, while vesicoamniotic shunting only improved survival without affecting renal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal intervention for severe lower urinary tract obstruction: a multicenter case-control study comparing fetal cystoscopy with vesicoamniotic shunting. Ruano, R., Sananes, N., Sangi-Haghpeykar, H., et al.[2016]

Fetal cystoscopy accurately diagnosed the cause of lower urinary tract obstruction (LUTO) in 91.4% of cases, allowing for targeted prenatal treatment.

Among fetuses diagnosed with posterior urethral valves (PUV), 56.7% survived to infancy, with 76.5% of those having normal renal function at 1 year, indicating that fetal cystoscopy can lead to improved outcomes for certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes after diagnostic and therapeutic fetal cystoscopy for lower urinary tract obstruction. Sananes, N., Cruz-Martinez, R., Favre, R., et al.[2017]

Fetoscopic techniques allow for safer prenatal surgical interventions by avoiding the risks associated with traditional open surgery, making it possible to treat conditions like congenital obstructive uropathy earlier in gestation.

In a study involving midgestation fetal lambs, an endoscopic approach using a new expandable wire mesh stent successfully corrected obstructive uropathy, suggesting that this method could improve bladder drainage and reduce the risks of preterm labor in fetuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic surgery for the treatment of congenital anomalies. Estes, JM., MacGillivray, TE., Hedrick, MH., et al.[2019]

Percutaneous fetal cystoscopy was successfully performed in 11 out of 13 fetuses with lower obstructive uropathy, allowing for direct visualization of the urinary tract and identification of conditions that ultrasound could not clarify.

The procedure not only helped diagnose issues like ureteral dilation and webs but also facilitated treatment options, such as urethral vesicoamniotic shunting, demonstrating its potential as a valuable tool in managing fetal urinary obstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-utero percutaneous cystoscopy in the management of fetal lower obstructive uropathy. Quintero, RA., Johnson, MP., Romero, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11717740/

Indications and Outcomes of Fetal Cystoscopy for Lower ... The evidence suggests that fetal cystoscopy is a challenging procedure, mainly indicated for severe LUTO with preserved fetal renal function.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03281798

Fetal Cystoscopy for Severe Lower Urinary Tract ... The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/abs/10.1002/pd.6721

Indications and Outcomes of Fetal Cystoscopy for Lower ... Current management strategies, including fetal vesicoamniotic shunting (VAS) and fetal cystoscopy, aim to alleviate obstruction and mitigate ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02446184

Fetal Cystoscopy for Lower Urinary Tract Obstruction This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20317022

Fetal Cystoscopy for Severe Lower Urinary Tract ... The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe, isolated lower urinary tract ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39694861/

Indications and Outcomes of Fetal Cystoscopy for Lower ... Fetal lower urinary tract obstruction (LUTO) encompasses a spectrum of rare congenital anomalies affecting the fetal urinary system, ...