Neurogenic Bladder Clinical Trial
— TSC-UROOfficial title:
Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
Verified date | December 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | University hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
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