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Clinical Trials/NCT04579731
NCT04579731
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country187 target enrollmentAugust 25, 2020

Overview

Phase
Not Applicable
Intervention
Lactitol Monohydrate
Conditions
Fecal Impaction
Sponsor
Seoul National University Hospital
Enrollment
187
Locations
1
Primary Endpoint
KUB (Kidneys, Ureters, Bladder)
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 25, 2020
End Date
June 2, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kwanjin Park

Associate Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients with having both significant Lowery Urinary Tract Dysfunction history suggestive of constipation (more than two positive criteria in ROME 4).
  • Parental recalling of hard stool (Bristol stool scale of 6 or 7).
  • Parental impression of constipation.

Exclusion Criteria

  • Those without Lower Urinary Tract Dysfunction or constipation.

Arms & Interventions

Lower Urinary Tract Dysfunction Not Related to Fecal Impaction

Patients with both significant Lower Urinary Tract Dysfunction history suggestive of constipation were treated with lactitol monohydrate syrup 10 g for eight weeks. Following eight weeks of treatment, patients were re-evaluated and those without symptom improvement place into lower urinary tract dysfunction not related to fecal impaction (LUTD-FI). They serve as a control group.

Intervention: Lactitol Monohydrate

Outcomes

Primary Outcomes

KUB (Kidneys, Ureters, Bladder)

Time Frame: After 8 weeks from the baseline

Examine the outcomes of the treatment of lactitol monohydrate 10 g in relation to Lower Urinary Tract Dysfunction and fecal impaction by using KUB (Kidneys, Ureters, Bladder) x-ray images.

Study Sites (1)

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