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

Seoul National University

Status: Invitation-only

Conditions: Neurogenic Bowel; Spina Bifida; Fecal Impaction; Fecal Incontinence; Neurogenic Bladder; Urinary Incontinence

Treatments: Device: Peristeen Transanal Irrigation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04815226

2102-095-1198

Details and patient eligibility

About

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

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Using Peristeen Transanal Irrigation

Other group

Description:

All participants in the trial will use Peristeen Transanal Irrigation. Eligible volunteers will be those patients who have failed conventional supportive bowel care, have neurogenic bladder, and use CIC (ClC: Clean Intermittent Catheterization) daily.

Treatment:

Device: Peristeen Transanal Irrigation