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

NCT04579731 | Completed DMC

• 1 other identifier: 2008-133-1150
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Impaction; Lower Urinary Tract Disorder; Bladder Dysfunction; Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• KUB (Kidneys, Ureters, Bladder)

  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.

  After 8 weeks from the baseline

Study Arms (2)

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

Interventions

Lactitol Monohydrate DRUG

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.

Lower Urinary Tract Dysfunction Not Related to Fecal Impaction

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the department of pediatric urology for significant lower urinary tract dysfunction with history suggestive of constipation.

You may qualify if:

• 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.

You may not qualify if:

• \- Those without Lower Urinary Tract Dysfunction or constipation.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Fecal Impaction; Intestinal Diseases

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Kwanjin Park, M.D. Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 8, 2020
• Study Start: August 25, 2020
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)