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

Completed

• Conditions: Bowel Dysfunction; Lower Urinary Tract Disorder; Bladder Dysfunction; Fecal Impaction
• Interventions: Drug: Lactitol Monohydrate

• Registration Number: NCT04579731
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2020-08-25
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-08
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower Urinary Tract Dysfunction Not Related to Fecal Impaction	Lactitol Monohydrate	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of