Bladder and Bowel Dysfunction in Children

NCT05318365 | Recruiting

• 1 other identifier: BBD_Children
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strategy for BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. This is, however, based on clinical experience and few retrospective, non-randomized studies and high-level evidence of the succession of the elements in treatment of BBD children is missing. Our microbiome, and its role in health and disease, has gained increased focus during the past years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. The microbiome in children is only sparsely investigated and its role in BBD is to the investigator's knowledge still unexplored. Study 1: Aim: To investigate if combination therapy is more effective in treating urinary incontinence in BBD children. Materials and methods: A prospective randomized multicentre study on children with BBD (n=100) between 5-14 years and 9 months old. They are randomized to: 1) Medical treatment of bowel symptoms (n=50) or 2) Medical treatment of bowel symptoms combined with standard urotherapy. The effect of treatment will be evaluated after 3 months. Primary endpoint: Resolution of incontinence after treatment. Secondary endpoint: Improved quality of life after successful treatment of urinary incontinence. Study 2: Aim: To investigate the urofecal microbiome in children with BBD Materials and methods:

1. 1.A cohort study to investigate, whether the urofecal microbiome can predict response to treatment and whether it changes during treatment period
2. 2.A case control study to investigate whether the urofecal microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's.

Conditions

Bladder and Bowel Dysfunction

Keywords

Dysfunctional Elimination Syndrome; Urinary Incontinence in Children; Functional constipation in Children; Gut Microbiome; Urine Microbiome

Outcome Measures

Primary Outcomes (1)

• Number of participants with reduction in weekly episodes of urinary incontinence

  No-response: \<50% reduction, Partial response: 50 to 99% reduction, Complete response: 100% reduction.

  Evaluation after 3 months of treatment

Secondary Outcomes (1)

• Number of participants with a change in quality of life after succesful treatment of urinary incontinence

  Evaluation after 3 months of treatment

Study Arms (2)

Treatment of constipation and/or faecal incontinence

ACTIVE COMPARATOR

Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition

Drug: Polyethylene Glycol 3350

Treatment of constipation and/or faecal incontinence combined with urotherapy

ACTIVE COMPARATOR

Medical treatment of bowel symptoms in accordance with the guidelines of The European Society for Paediatric Gastroenterology, Hepatology and Nutrition combined with standard urotherapy in accordance with International Children's Continence Society (ICCS)

Drug: Polyethylene Glycol 3350; Behavioral: Urotherapy

Interventions

Polyethylene Glycol 3350 DRUG

PEG3350, klysma, laxoberal and magnesia will be administered in accordance with actual guidelines for treatment of constipation in children

Also known as: Magnesia, Laxoberal, Glyoktylklysma

Treatment of constipation and/or faecal incontinence; Treatment of constipation and/or faecal incontinence combined with urotherapy

Urotherapy BEHAVIORAL

Information and demystification of the disorder along with behavioural modification such as timed voiding, proper voiding posture, avoidance of holding manoeuvers and balanced fluid intake

Treatment of constipation and/or faecal incontinence combined with urotherapy

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with urinary incontinence and/or enuresis nocturna defined by the ICCS criteria
• Diagnosed with constipation and/or faecal incontinence defined by the ROME IV criteria
• Normal clinical examination
• Parents/guardian can understand the written and spoken information
• Informed assent to participation from both parents/guardian

You may not qualify if:

• Neuropathic or anatomical abnormalities in the urinary tract or gastrointestinal canal
• Earlier surgical intervention of the urinary tract (except circumcision)
• Neurological illness or earlier cerebral surgical intervention
• On-going urinary tract infection
• On-going treatment with anticholinergics and/or β3-adenoceptoragonist
• On-going treatment with laxatives in correct dosage (PEG3350 1-2 g/kg/day)
• Inflammatory bowel disease
• Other disorder affection bladder or bowel function
• For Study 2 (microbiome): Systemic antibiotics within the past 3 months

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Goedstrup Regional Hospital

Herning, 7400, Denmark

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Intestinal Diseases

Interventions

polyethylene glycol 3350; Magnesium Oxide; picosulfate sodium

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Sofie Axelgaard, MD

  Department of Childhood and Adolescent Medicine, Regional Hospital Goedstrup

  STUDY CHAIR

• Soeren Hagstroem, Professor, MD

  Department of Childhood and Adolescent Medicine, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

• Luise Borch, MD, PhD

  Department of Childhood and Adolescent Medicine, Regional Hospital Goedstrup

  STUDY DIRECTOR

• Konstantinos Kamperis, MD, PhD

  Department of Childhood and Adolescent Medicine, Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sofie Axelgaard, MD

CONTACT

+45 61460024; sofiaxel@rm.dk

Luise Borch, MD, PhD

CONTACT

+45 78433654; luise.borch@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 8, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)