Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

Neurogenic Bladder Clinical Trial

— TSC-URO  

Official title:

Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182853
• Other study ID #: RECHMPL21_0377
• Status: Completed
• Start date: June 16, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 1, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion criteria:

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

Exclusion criteria:

• Associated anorectal malformation
• Associated neurological pathology

Related Conditions & MeSH terms

• Neurogenic Bladder
• Sacrococcygeal Teratoma
• Teratoma
• Urinary Bladder, Neurogenic
• Voiding Disorders

Locations

Country	Name	City	State
France	University hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of voiding disorders	Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system	Day 1
Secondary	Presence of defecation disorders	The Presence of defecation disorders will be assessed by the scale: Bristol stool scale	Day 1
Secondary	Presence of secondary neurological bladder	the Presence of secondary neurological bladder will be assessed by the uroflowmetry	Day 1