Early Infancy Ureteral Reimplantation for Distal Ureteral Obstruction

NCT02419339 | Terminated

• 1 other identifier: 0368-15-EP
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective multicenter observational study of early infancy ureteral reimplantation for distal ureteral obstruction. The study is an observation study since the investigators will not assign specific interventions to the subjects of the study. The purpose of the study is to describe the surgical outcomes of early infancy ureteral reimplantation. Infants under 6 months of age with unilateral obstructed distal ureter, no other urologic pathologic and a normal contralateral kidney who have been recommended a ureteral reimplant by their pediatric urologist are eligible for the study. Patients that consent for the study will be prospectively followed for 1 year to record the outcomes of the surgery.

Conditions

Ureteral Obstruction; Urinary Diversion

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Need for reoperation either for persistent documented obstruction or reflux with recurrent febrile UTI's

  1 year

Secondary Outcomes (1)

• Recurrent Febrile UTI's

  1 year

Interventions

Extravesical ureteral reimplantation PROCEDURE

Extravesical ureteral reimplantation with or without tapering

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants (under 6 months of age) undergoing an extravesical ureteral reimplant for primary obstructed megaureter or ectopic ureter.

You may qualify if:

• Children younger 6 months of age who have been recommended by their urologist to have a unilateral ureteral reimplant.
• Unilateral obstructive disease (as defined by the BAPU)
• Ipsilateral Single system
• Ipsilateral VUR is ok
• Contralateral reflux grades 1-3 ok as long as the reflux will be observed

You may not qualify if:

• Duplicated systems
• First Febrile UTI's and megaureter or ectopic ureter but no evidence of obstruction or loss of function
• Neurogenic bladder, valves
• Contralateral reflux grade 4-5

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Children's Hospital and Medical Center

Omaha, Nebraska, 68114, United States

Location

Related Publications (13)

• de Jong TP, Dik P, Klijn AJ, Uiterwaal CS, van Gool JD. Ectopic ureterocele: results of open surgical therapy in 40 patients. J Urol. 2000 Dec;164(6):2040-3; discussion 2043-4.

  PMID: 11061921 BACKGROUND

• de Kort LM, Klijn AJ, Uiterwaal CS, de Jong TP. Ureteral reimplantation in infants and children: effect on bladder function. J Urol. 2002 Jan;167(1):285-7. doi: 10.1097/00005392-200201000-00084.

  PMID: 11743341 BACKGROUND

• Gearhart JP. Primary obstructive ureter in neonates. Treatment by temporary uretero-cutaneostomy. Br J Urol. 1994 Jul;74(1):133-4. No abstract available.

  PMID: 8044519 BACKGROUND

• Greenfield SP, Griswold JJ, Wan J. Ureteral reimplantation in infants. J Urol. 1993 Nov;150(5 Pt 1):1460-2. doi: 10.1016/s0022-5347(17)35809-3.

  PMID: 8411425 BACKGROUND

• Kaefer M, Misseri R, Frank E, Rhee A, Lee SD. Refluxing ureteral reimplantation: a logical method for managing neonatal UVJ obstruction. J Pediatr Urol. 2014 Oct;10(5):824-30. doi: 10.1016/j.jpurol.2014.01.027. Epub 2014 Feb 28.

  PMID: 24850437 BACKGROUND

• Kitchens DM, DeFoor W, Minevich E, Reddy P, Polsky E, McGregor A, Sheldon C. End cutaneous ureterostomy for the management of severe hydronephrosis. J Urol. 2007 Apr;177(4):1501-4. doi: 10.1016/j.juro.2006.11.076.

  PMID: 17382764 BACKGROUND

• Kogan BA, Gohary MA. Cutaneous ureterostomy as a permanent external urinary diversion in children. J Urol. 1984 Oct;132(4):729-31. doi: 10.1016/s0022-5347(17)49844-2.

  PMID: 6471219 BACKGROUND

• Lee SD, Akbal C, Kaefer M. Refluxing ureteral reimplant as temporary treatment of obstructive megaureter in neonate and infant. J Urol. 2005 Apr;173(4):1357-60; discussion 1360. doi: 10.1097/01.ju.0000152317.72166.df.

  PMID: 15758801 BACKGROUND

• Liu C, Chin T, Wei C. Surgical treatment of vesicoureteral reflux in infants under 3 months of age. J Pediatr Surg. 1998 Nov;33(11):1716-9. doi: 10.1016/s0022-3468(98)90617-0.

  PMID: 9856903 BACKGROUND

• MacGregor PS, Kay R, Straffon RA. Cutaneous ureterostomy in children--long-term followup. J Urol. 1985 Sep;134(3):518-20. doi: 10.1016/s0022-5347(17)47271-5.

  PMID: 4032552 BACKGROUND

• Peters CA, Mandell J, Lebowitz RL, Colodny AH, Bauer SB, Hendren WH, Retik AB. Congenital obstructed megaureters in early infancy: diagnosis and treatment. J Urol. 1989 Aug;142(2 Pt 2):641-5; discussion 667-8. doi: 10.1016/s0022-5347(17)38842-0.

  PMID: 2746792 BACKGROUND

• Sarduy GS, Crooks KK, Smith JP, Wise HA 2nd. Results in children managed by cutaneous ureterostomy. Urology. 1982 May;19(5):486-8. doi: 10.1016/0090-4295(82)90604-5.

  PMID: 7080321 BACKGROUND

• Farrugia MK, Hitchcock R, Radford A, Burki T, Robb A, Murphy F; British Association of Paediatric Urologists. British Association of Paediatric Urologists consensus statement on the management of the primary obstructive megaureter. J Pediatr Urol. 2014 Feb;10(1):26-33. doi: 10.1016/j.jpurol.2013.09.018. Epub 2013 Oct 16.

  PMID: 24206785 BACKGROUND

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

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

Study Officials

• Carlos A Villanueva, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 17, 2015
• Study Start: May 22, 2015
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

US (1)