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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using Peristeen Transanal Irrigation | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peristeen Transanal Irrigation | Device | Using Peristeen Transanal Irrigation twice per week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the dip stick urinalysis | Baseline |
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 4 weeks |
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 8 weeks |
| Change in nitrite and leukocyte esterase | Either complete or partial reduction of nitrite and leukocyte esterase on the | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Korean Neurogenic Bowel Dysfunction Score |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kwanjin Park, M.D. Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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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 |
| 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 |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D055496 | Neurogenic Bowel |
| D016135 | Spinal Dysraphism |
| D005242 | Fecal Incontinence |
| D005244 | Fecal Impaction |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012002 | Rectal Diseases |
| D007415 | Intestinal Obstruction |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
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