Clinical Trials Directory

Trials / Completed

CompletedNCT04579731

Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction

Status
Completed
Phase
Study type
Observational
Enrollment
187 (actual)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
5 Years – 13 Years
Healthy volunteers
Not accepted

Summary

The role of bowel bladder disorder, or BBD, has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (UTI). However, the diagnosis of BBD are still conceptual and subjective, because of the diagnosis of constipation, main pathophysiology in BBD has not been established well.

Detailed description

Functional constipation is a common disorder among children, accounting for 3-5% of visits to pediatric clinics and even 10% to 25% of consultation for pediatric gastroenterologists. It could cause recurrent abdominal pain, stool retention as well as fecal incontinence. In the urologic field, this is known to develop urinary symptoms. Constipation has been associated with voiding dysfunction and urinary tract infection in children. It is assumed that impacted stool in distal rectum mechanically affect the bladder leading to detrusor overactivity. Additionally, impacted stool would elevate the uretheral sphincter tone, having patients void with incomplete sphincter relaxation and eliciting dysfunctional voiding. Stool impaction may be the source of bacteria causing urinary tract infection and led to recurrent bacteriuria. Treatment of constipation by itself is quite effective alleviating urologic symptoms in as much as two-third of the patients. The role of constipation has been highlighted as a major player in vesicoureteral reflux and urinary tract infection (UTI). The presence of bowel bladder disorder (BBD) was associated with higher risk of breakthrough infection and a lack of spontaneous resolution. Although constipation is the major player in BBC, there is any objective standard regarding the diagnosis and treatment of constipation. Given the high prevalence and morbidity of children affected by UTI or VUR in relations to BBD, it is imperative that diagnostic and treatment methods are developed. Despite the known implication of constipation, the diagnosis of constipation may be problematic due to a lack of standard definition for this condition. This may be due to different views between clinicians about which aspect are most crucial for diagnosing constipation. Some underline the subjective nature such as infrequent or difficult defecation, other stress the quality of stool, still others were in search of objective criteria of constipation, like the amount of impacted stool or colonic transit time. Consequently, various criteria have been reported. The lack of standard criteria for constipation causes trouble sometimes in making a proper decision for diagnosis, intervention, follow-up, and discharge of treatment.

Conditions

Interventions

TypeNameDescription
DRUGLactitol MonohydratePatients with lower urinary tract dysfunction and assumed to have constipation were placed on lactitol monohydrate 10 g for 8 weeks, and had re-evaluated.

Timeline

Start date
2020-08-25
Primary completion
2021-06-02
Completion
2021-06-02
First posted
2020-10-08
Last updated
2021-08-10

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04579731. Inclusion in this directory is not an endorsement.