Fetal Cystoscopy for Lower Urinary Tract Obstruction

NCT02446184 | Terminated DMC

• 1 other identifier: BCM H33626
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to evaluate the safety, feasibility, and effectiveness of fetal cystoscopy as an experimental procedure in avoiding perinatal death and renal impairment and to compare to the investigators clinical experience with fetal vesicoamniotic shunting.

Conditions

Urethral Obstruction

Keywords

urethral obstruction; posterior urethral valves; lower urinary tract obstruction

Outcome Measures

Primary Outcomes (1)

• Postnatal survival at 2 years of life

  We will evaluate the survival rate at 2 years of life

  2 years

Secondary Outcomes (1)

• Postnatal renal function at 2 years of life

  2 years

Study Arms (3)

Fetal cystoscopy

EXPERIMENTAL

Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.

Procedure: Fetal Cystoscopy

Vesicoamniotic shunt

ACTIVE COMPARATOR

The fetal vesicoamniotic shunt is considered the standard prenatal therapy for severe LUTO. Amnioinfusion and vesicoamniotic shunt placement will be performed under ultrasound guidance.

Procedure: Fetal vesicoamniotic shunt

No fetal intervention group

NO INTERVENTION

Those patients that refuse fetal intervention and do not elect to terminate the pregnancy will be followed as part of the no fetal intervention group.

Interventions

Fetal Cystoscopy PROCEDURE

Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.

Fetal cystoscopy

Fetal vesicoamniotic shunt PROCEDURE

Fetal vesicoamniotic shunt will be performed under ultrasound guidance

Also known as: Bladder shunt

Vesicoamniotic shunt

Eligibility Criteria

• Age: 16 Weeks - 26 Weeks
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
• Oligohydramnios or Anhydramnios after 18 weeks
• "Favorable urine analysis after 18 weeks (urinary sodium is \< 100mEq/L, chloride \< 90mEq/L, osmolarity \<200mOsm/L and β2-microglobulin \<6mg/L 7)
• Absence of chromosomal abnormalities and associated anomalies (Normal karyotype by invasive testing (amniocentesis or CVS))
• Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks

You may not qualify if:

• Fetal anomaly unrelated to LUTO
• Congenital cardiac anomaly
• 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 - A body-mass index ≥ 35
• 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 a support person (ie. Spouse, partner, mother) available to support the patient for the duration of the pregnancy at Texas Children's Hospital/Ronald McDonald House
• Patient does not have healthy insurance to cover routine clinical care at Texas Children's Hospital 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 the 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital Pavilion for Women

Houston, Texas, 77030, United States

Location

Related Publications (9)

• Ruano R, Pimenta EJ, Duarte S, Zugaib M. Four-dimensional ultrasonographic imaging of fetal lower urinary tract obstruction and guidance of percutaneous cystoscopy. Ultrasound Obstet Gynecol. 2009 Feb;33(2):250-2. doi: 10.1002/uog.6292. No abstract available.

  PMID: 19173237 RESULT

• Ruano R, Duarte S, Bunduki V, Giron AM, Srougi M, Zugaib M. Fetal cystoscopy for severe lower urinary tract obstruction--initial experience of a single center. Prenat Diagn. 2010 Jan;30(1):30-9. doi: 10.1002/pd.2418.

  PMID: 19967749 RESULT

• Ruano R, Yoshisaki CT, Salustiano EM, Giron AM, Srougi M, Zugaib M. Early fetal cystoscopy for first-trimester severe megacystis. Ultrasound Obstet Gynecol. 2011 Jun;37(6):696-701. doi: 10.1002/uog.8963.

  PMID: 21337440 RESULT

• Morris RK, Ruano R, Kilby MD. Effectiveness of fetal cystoscopy as a diagnostic and therapeutic intervention for lower urinary tract obstruction: a systematic review. Ultrasound Obstet Gynecol. 2011 Jun;37(6):629-37. doi: 10.1002/uog.8981. Epub 2011 May 16.

  PMID: 21374748 RESULT

• Ruano R. Fetal surgery for severe lower urinary tract obstruction. Prenat Diagn. 2011 Jul;31(7):667-74. doi: 10.1002/pd.2736. Epub 2011 Mar 17.

  PMID: 21413041 RESULT

• Ethun CG, Zamora IJ, Roth DR, Kale A, Cisek L, Belfort MA, Haeri S, Ruano R, Welty SE, Cassady CI, Olutoye OO, Cass DL. Outcomes of fetuses with lower urinary tract obstruction treated with vesicoamniotic shunt: a single-institution experience. J Pediatr Surg. 2013 May;48(5):956-62. doi: 10.1016/j.jpedsurg.2013.02.011.

  PMID: 23701767 RESULT

• Ruano R, Yoshizaki CT, Giron AM, Srougi M, Zugaib M. Cystoscopic placement of transurethral stent in a fetus with urethral stenosis. Ultrasound Obstet Gynecol. 2014 Aug;44(2):238-40. doi: 10.1002/uog.13293. Epub 2014 Jun 26.

  PMID: 24375864 RESULT

• Sananes N, Favre R, Koh CJ, Zaloszyc A, Braun MC, Roth DR, Moog R, Becmeur F, Belfort MA, Ruano R. Urological fistulas after fetal cystoscopic laser ablation of posterior urethral valves: surgical technical aspects. Ultrasound Obstet Gynecol. 2015 Feb;45(2):183-9. doi: 10.1002/uog.13405.

  PMID: 24817027 RESULT

• Ruano R, Sananes N, Sangi-Haghpeykar H, Hernandez-Ruano S, Moog R, Becmeur F, Zaloszyc A, Giron AM, Morin B, Favre R. Fetal intervention for severe lower urinary tract obstruction: a multicenter case-control study comparing fetal cystoscopy with vesicoamniotic shunting. Ultrasound Obstet Gynecol. 2015 Apr;45(4):452-8. doi: 10.1002/uog.14652. Epub 2015 Mar 2.

  PMID: 25157756 RESULT

MeSH Terms

Conditions

Urethral Obstruction

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michael A Belfort, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Rodrigo Ruano, MD, PhD

  Baylor Colleg of Medicine (Previously); Mayo Clinic (currently)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Professor Baylor College of Medicine and Co-Director Texas Children's Fetal Center

Model Details: This study is an un-blinded, non-randomized, single arm Phase 1 study. Fetal intervention is usually offered to patients carrying fetuses with isolated LUTO that meet the inclusion criteria. Once the patient elected to have fetal intervention, fetal cystoscopy will be offered as an experimental procedure as an option to fetal vesico-amniotic shunting.

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 18, 2015
• Study Start: December 4, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 23, 2016
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)