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Completed

NCT Number: NCT05182853

Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

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.

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Key information

Conditions

Sacrococcygeal Teratoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Nervous System Diseases Neurogenic Bladder Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Teratoma Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Voiding Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Associated anorectal malformation
  • Associated neurological pathology

Treatment and study plan

Primary outcomes

  1. Presence of voiding disorders

    Time frame: Day 1

    Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system

Secondary outcomes

  1. Presence of defecation disorders

    Time frame: Day 1

    The Presence of defecation disorders will be assessed by the scale: Bristol stool scale

  2. Presence of secondary neurological bladder

    Time frame: Day 1

    the Presence of secondary neurological bladder will be assessed by the uroflowmetry

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: TSC-URO

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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