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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04579731
Collaborator
(none)
187
1
9.2
20.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lactitol Monohydrate

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.

Study Design

Study Type:
Observational
Actual Enrollment :
187 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction
Actual Study Start Date :
Aug 25, 2020
Actual Primary Completion Date :
Jun 2, 2021
Actual Study Completion Date :
Jun 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Fecal Impaction (LUTD-FI)

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 with 50% of symptom improvement were assumed to have a significant improvement attributable to the development of Lower Urinary Tract Dysfunction- Fecal Impaction (LUTD-FI).

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.

Drug: Lactitol Monohydrate
Patients with lower urinary tract dysfunction and assumed to have constipation were placed on lactitol monohydrate 10 g for 8 weeks, and had re-evaluated.

Outcome Measures

Primary Outcome Measures

  1. KUB (Kidneys, Ureters, Bladder) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Principal Investigator: Kwanjin Park, M.D. Ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kwanjin Park, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04579731
Other Study ID Numbers:
  • 2008-133-1150
First Posted:
Oct 8, 2020
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2021