The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection

Urinary Incontinence Clinical Trial

Official title:

The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection in Patients With Neurogenic Bladder: a Prospective, Explorative Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04815226
• Other study ID #: 2102-095-1198
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.

Description:

This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients diagnosed with neurogenic bladder. It is a prospective exploratory pilot study, and the participants will be asked to perform transanal irrigation twice weekly for 12 weeks (three months). At each visit, including baseline, the study endpoints will be assessed by basic urinalysis, KUB imaging, Seoul Fecal Scoring, and a survey (Korean Neurogenic Bowel Score).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Between the ages, 5 to 18, and are diagnosed with neurogenic bladder.

• Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder.

• A recent history of fecal incontinence within the last 3 months

• More than two episodes of urinary tract infection and/ or pyuria within the last 6 months

Exclusion Criteria:

• An anatomical abnormality of the bladder neck.

• Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment.

• Received bladder augmentation surgery

• Patient without completion of toilet training

• Either received following treatment diagnosed according to Peristeen® product safety guideline:

1. Anorectal malformation

2. Colorectal cancer

3. Endoscopic polyp removal surgery in 3 months

4. Ischemic colitis

5. Acute inflammatory bowel disease

6. Acute intestinal diverticulum.

7. Radiotherapy to the colon

8. Long-term corticosteroid usage

Related Conditions & MeSH terms

• Fecal Impaction
• Fecal Incontinence
• Neurogenic Bladder
• Neurogenic Bowel
• Spina Bifida
• Spinal Dysraphism
• Urinary Bladder, Neurogenic
• Urinary Incontinence
• Urinary Tract Infections

Intervention

Device:
• Peristeen Transanal Irrigation
Using Peristeen Transanal Irrigation twice per week for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Coloplast A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nitrite and leukocyte esterase	Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis	Baseline
Primary	Change in nitrite and leukocyte esterase	Either complete or partial reduction of nitrite and leukocyte esterase on the	4 weeks
Primary	Change in nitrite and leukocyte esterase	Either complete or partial reduction of nitrite and leukocyte esterase on the	8 weeks
Primary	Change in nitrite and leukocyte esterase	Either complete or partial reduction of nitrite and leukocyte esterase on the	12 weeks
Secondary	Seoul Fecal Scoring	Measuring the amount of feces in the abdomen using the images obtained from KUB (Kidney, Ureter, Bladder) x-ray.	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Korean Neurogenic Bowel Dysfunction Score	Quality of life and bowel symptom changes after using Peristeen Transanal Irrigation. 0 being having excellent quality of life and least bowel symptom changes, and 47 being the highest with extremely low QoL	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Safety efficacy of Peristeen Transanal Irrigation	Incidence of adverse events while using Peristeen Transanal Irrigation throughout the trial using self designed questionnaire	4 weeks, 8 weeks, 12 weeks