Lower Urinary Tract Obstruction, CongenitalNCT07572227
Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
A study testing Fetal cystoscope in people with Lower Urinary Tract Obstruction, Congenital, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lower Urinary Tract Obstruction, Congenital
- What is being tested?
- Fetal cystoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 23 Mar 2060
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Fetal cystoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal cystoscopeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Fetal operative cystoscopy | Experimental | Patients pregnant with a male baby who has a lower urinary tract obstruction Receives: Device: Fetal cystoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
Measured: 24 months
Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Technical success of posterior urethral valve ablation with laser to allow passage of balloon is defined as completing urethral valve ablation during the procedure.
Measured: 24 months
Number of procedures that achieved technical success of valvuloplasty
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
Measured: 24 months
Secondary outcomes (18)
Amniotic fluid volume after the procedure (major vertical pocket)
Amniotic fluid volume is reported based on ultrasound measurements of Maximum Vertical Pocket (MVP), and is reported in centimeters (cm)
Measured: 24 hours after procedure
Fetal lung growth after treatment
Fetal lung growth will be determined by observed Lung area to Head circumference Ratio (LHR) = Lung area / Head circumference
Measured: Baseline
Number of fetuses to experience complications
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
Measured: Baseline
Number of mothers to experience complications
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.
Measured: Baseline
Gestational age at delivery
Gestational age at time of delivery, reported in weeks
Measured: Gestational age at delivery, up to 9 months
Renal changes after treatment
Number of patients to experience renal pelvis anteroposterior diameter, presence or absence of renal cystic changes, improvement or worsening of hydronephrosis
Measured: 24 months
Survival rate
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
Measured: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Serum creatinine level
Serum creatinine level will be measured by blood test
Measured: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Need for dialysis
Number of neonates to require dialysis
Measured: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Grading of oxygen dependency
Grading of oxygen dependency is categorized as: none, mild, moderate, or severe
Measured: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Occurrence of severe pulmonary hypertension
Number of neonates to show indications of severe pulmonary hypertension based on latest echocardiogram during first hospitalization.
Measured: Baseline
Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Number of neonates to require ECMO support at any point during the first 24 months
Measured: 24 months
Days in neonatal intensive care unit during the first hospitalization
Total number of days in neonatal intensive care unit during the first hospitalization
Measured: During first hospitalization (assessed up to 10 days)
Ventilator support during the first hospitalization
Total number of days of ventilator support during the first hospitalization
Measured: During first hospitalization (assessed up to 10 days)
Presence of neonatal sepsis
Total number of neonates to experience neonatal sepsis, defined as intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher).
Measured: Baseline
Total number of patients to require surgery
Total number of patients to require surgery to treat posterior urethral valves or to deal with complications of in utero procedure
Measured: Baseline
Days of maternal hospitalization.
Total number of days in hospital after giving birth
Measured: Two weeks from day of admission
Operative times
Length of time to complete fetal cystoscopy, reported in minutes
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start8 May 2026
- Primary completion23 Mar 2056 (estimated)
- Study completion23 Mar 2060 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract Obstruction, CongenitalStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 10 pregnant women carrying a singleton gestation and male fetus with lower urinary tract obstruction will be enrolled as subjects. Mothers and babies will be followed for 24 months post delivery for outcomes.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro H. Schenone, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572227
- Sponsor's protocol ID
- 23-008546
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Cystoscopy in the Management of Lower Urinary Tract Obstruction (LUTO)
- ClinicalTrials.gov ID
- NCT07572227
- Acronym / sponsor ID
- 23-008546
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 23 Mar 2056 (estimated)
- Study completion
- 23 Mar 2060 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 10 pregnant women carrying a singleton gestation and male fetus with lower urinary tract obstruction will be enrolled as subjects. Mothers and babies will be followed for 24 months post delivery for outcomes.
| Arm | Type | Receives |
|---|---|---|
| Fetal operative cystoscopy | Experimental | Device: Fetal cystoscopePatients pregnant with a male baby who has a lower urinary tract obstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- Severe maternal health condition precluding procedure.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal cystoscopeThe 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. | Device | Fetal operative cystoscopy |
Primary outcome
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra
Time frame: 24 months
Technical success of visualization is defined as the ability to visualize the bladder neck and proximal urethra during the procedures.
Number of procedures that achieved technical success of posterior urethral valve ablation with laser to allow passage of balloon
Time frame: 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.
Number of procedures that achieved technical success of valvuloplasty
Time frame: 24 months
Technical success of valvuloplasty is defined as passage of balloon during dilation of valve.
18 secondary outcomes
Amniotic fluid volume after the procedure (major vertical pocket)
Time frame: 24 hours after procedure
Fetal lung growth after treatment
Time frame: Baseline
Number of fetuses to experience complications
Time frame: Baseline
Number of mothers to experience complications
Time frame: Baseline
Gestational age at delivery
Time frame: Gestational age at delivery, up to 9 months
Renal changes after treatment
Time frame: 24 months
Survival rate
Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Serum creatinine level
Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Need for dialysis
Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Grading of oxygen dependency
Time frame: 28 days, 3 months, 6 months, 12 months, 18 months, and 24 months of age
Occurrence of severe pulmonary hypertension
Time frame: Baseline
Use of extracorporeal membrane oxygenation (ECMO) support during post-natal follow-up
Time frame: 24 months
Days in neonatal intensive care unit during the first hospitalization
Time frame: During first hospitalization (assessed up to 10 days)
Ventilator support during the first hospitalization
Time frame: During first hospitalization (assessed up to 10 days)
Presence of neonatal sepsis
Time frame: Baseline
Total number of patients to require surgery
Time frame: Baseline
Days of maternal hospitalization.
Time frame: Two weeks from day of admission
Operative times
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Lower Urinary Tract Obstruction, Congenital
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingObservational study
Standardized Prenatal Clinical Care for LUTO
Urethral Obstruction
Recruiting
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital
RecruitingObservational study
Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauro H. Schenone, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal cystoscope in people with Lower Urinary Tract Obstruction, Congenital, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedures that achieved technical success of visualization of the bladder neck and proximal urethra (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.