Fecal ImpactionNCT04579731
Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction
An observational study of Fecal Impaction and Lower Urinary Tract Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Fecal Impaction, Lower Urinary Tract Disorder, Bladder Dysfunction
- What is being tested?
- Lactitol Monohydrate
- Type of treatment
- Pill or oral medicine
- How many people
- 187 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Aug 2020to 2 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who visited the department of pediatric urology for significant lower urinary tract dysfunction with history suggestive of constipation.
Who may be able to join
- 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.
Who cannot join
- Those without Lower Urinary Tract Dysfunction or constipation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Lactitol Monohydrate
- Medical subject headings
- Fecal Impaction, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactitol MonohydrateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lactitol Monohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 8 weeks from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start25 Aug 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal ImpactionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwanjin Park, Seoul National University Hospital
- Investigators
- Kwanjin Park, M.D. Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579731
- Sponsor's protocol ID
- 2008-133-1150
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2020
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Fecal Scoring for the Management of Fecal Impaction With Regards to Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT04579731
- Acronym / sponsor ID
- 2008-133-1150
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Lactitol MonohydratePatients 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who visited the department of pediatric urology for significant lower urinary tract dysfunction with history suggestive of constipation.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those without Lower Urinary Tract Dysfunction or constipation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactitol MonohydratePatients with lower urinary tract dysfunction and assumed to have constipation were placed on lactitol monohydrate 10 g for 8 weeks, and had re-evaluated. | Drug | Lower Urinary Tract Dysfunction Not Related to Fecal Impaction |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwanjin Park, M.D. Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fecal Impaction and Lower Urinary Tract Disorder, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KUB (Kidneys, Ureters, Bladder) (time frame: After 8 weeks from the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.