Rochester, MNNCT03281798Now EnrollingIRB Ready

Lower Urinary Tract Obstructive Syndrome Clinical Trial in Rochester, MN

Access cutting-edge lower urinary tract obstructive syndrome treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by Rodrigo Ruano

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Expert Care in Rochester

Access lower urinary tract obstructive syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related lower urinary tract obstructive syndrome treatment provided free

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Check if you qualify for this lower urinary tract obstructive syndrome clinical trial in Rochester, MN

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for MN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Lower Urinary Tract Obstructive Syndrome Study in Rochester

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 obstruction (LUTO).

Sponsor: Rodrigo Ruano

Who Can Participate

Inclusion Criteria

Pregnant women
Singleton pregnancy
Maternal age ≥ 18 years
Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
Oligohydramnios or Anhydramnios
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).
Absence of chromosomal abnormalities and associated anomalies
Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
Parents or guardian are willing to provide signed informed consent.

Exclusion Criteria

Fetal anomaly unrelated to LUTO
Congenital cardiac anomaly
Female fetus
Increased risk for preterm labor including short cervical length (\<1.5 cm), 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
Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
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. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Maternal medical condition that is a contraindication to surgery or anesthesia
Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
Inability to comply with travel and follow-up requirements of the trial
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Patients declining invasive testing
Family does not meet psychosocial criteria including insufficient

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT03281798) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lower Urinary Tract Obstructive Syndrome Treatment Options in Rochester, MN

If you're searching for lower urinary tract obstructive syndrome treatment options in Rochester, MN, this clinical trial (NCT03281798) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced lower urinary tract obstructive syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lower urinary tract obstructive syndrome clinical trials near you to find additional studies recruiting in your area.

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