Voiding Disorders in Children After Sacrococcygeal Teratoma Resection (TSC-URO)

Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results [Cozzi et al., 2008; Draper et al., 2009]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia [Hambraeus et al., 2018] and rise concerned about long-term renal function [Khanna et al., 2019; Rehfuss et al., 2020] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.

Study Overview

• Status: Completed
• Conditions: Voiding Disorders; Neurogenic Bladder; Sacrococcygeal Teratoma

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal malformation or any other neurological pathology

Description

Inclusion criteria:

• Children aged 6 to 18
• history of sacrococcygeal teratoma resection

Exclusion criteria:

• Associated anorectal malformation
• Associated neurological pathology

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of voiding disorders	Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of defecation disorders	The Presence of defecation disorders will be assessed by the scale: Bristol stool scale	Day 1
Presence of secondary neurological bladder	the Presence of secondary neurological bladder will be assessed by the uroflowmetry	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Sarah GARNIER, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (ACTUAL): January 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: children; urinary incontinence; neurogenic bladder; Teratoma; sacrococcygeal region
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Neoplasms, Germ Cell and Embryonal; Urinary Bladder, Neurogenic; Teratoma
• Other Study ID Numbers: RECHMPL21_0377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No