Prospective trial of using transanal irrigation system (Peristeen®) for patients with bowel dysfunction in Japan

Sakoda A1, Suzuki M1, Yago R1, Tanabe K1

Research Type

Clinical

Abstract Category

Anorectal / Bowel Dysfunction

Abstract 796
Non Discussion Abstract
Scientific Non Discussion Abstract Session 37
Incontinence Bowel Evacuation Dysfunction Quality of Life (QoL)
1.Department of Urology, Tokyo Women's Medical University
Links

Abstract

Hypothesis / aims of study
In Japan, “home washing bowel management guidance fee” (Education fee for home transanal irrigation) using Peristeen® has just settled in national medical insurance system last year only for the patients with spina bifida (SB) and spinal cord injury (SCI).  For the further improvement of Peristeen® as a device for transanal irrigation and to assess adequate fee for expanding medical insurance service to the other bowel dysfunction disorders, 3 months prospective trial of using Peristeen® was performed in our institution.
Study design, materials and methods
Nine patients with SB (n=6) and SCI (n=3) were enrolled the trial.  To evaluate the severity of bowel dyfunction, NBD (neurogenic bowel dysfunction) score (1) was conducted.  For estimating comfortableness, VAS (visual analogue scale) score was used. Both scores before and (2 and 10 weeks) after initiating Peristeen® were compared.  Required time for bowel management inside of the toilet was also compared.  Instructions for using Peristeen® were provided for all patients and care persons directly from physicians and nurses with demonstration of balloon catheter inflation, deflation, insertion, and control pumping strength for irrigation.  Volume of the water was started with 10ml/kg.  Three points of score check seats were filled with patient and care person face to face at outpatient clinic.  Telephone interview was undergone for the patient who could not come on the check point day.
Results
Of 9 patients, 6 were SB (median age 14.5: range 3-43, M:F=0:6) and 3 were SCI (median age: 36 range 18-47, M:F=2:1).  All patients were under CIC (catheterization-clean intermittent) control with voiding dysfunction and 4 patients were using wheelchair.  Five out of 9 (55.6%), (3: SB and 2: SCI) patients dropped out the trial.  Main reason for cessation was unstability of balloon catheter.  Patients required holding catheter all the time to prevent leakage during pumping water, otherwise it easily comes out.  Four of 5 ceased patients already had own transanal irrigation instrument and they preferred familiar system.  One patient stopped using Peristeen® because of its complexity and return to heavy user of laxatives.  Four out of 9 (44.4%), (3: SB and 1: SCI) patients accomplished 3 months trial.  NBD score was slightly decreased and VAS score was increased. Maximum improvement range of VAS score was 8.3.  Before initiating Peristeen® they were using regular enema and several laxatives with manual evacuation.  Patients were always worryng about incontinence with uncontrolled bowel function.  Patients and their family’s feel of safety increased VAS score.  Average time required for bowel management inside toilet before and after using Peristeen® was 101(4-300) and 67.5(30-180) minutes respectively.  All success patients had no experience of transanal irrigation before this trail. Three SB patients were children.  Reason for success was existence of the supportive care person next to them.  Among accomplished patients, 2 patients had difficulty in moving toilet.  They managed to use Peristeen® on the floor or special toilet.  For small child, less than 7 years old, balloon catheter was well stabilized with no leakage, but watchful follow up is essential.  We have to lead them to do irrigation by themselves.  There are a lot of improvement points to coordinate better bowel management for the patients with bowel dysfunction, Peristeen® would be one of the good tool for transanal irrigation.
Interpretation of results
Peristeen® was effective transanal irrigation system especially for the young patients with supportive care person. To increase the user, improvement of the balloon catheter would be expected.
Concluding message
Prospective trail of Peristeen® transanal irrigation system was performed in our institution.  Peristeen® transanal irrigation system improved patients’ quality of life, but could not take place conventional instrument for the patients who already had own way to perform transanal irrigation.  To increase the Peristeen® user including the other bowel dysfunction disorders, thoughtful discussion should be done regarding national medical expenses with health insurance coverage. This is another upcoming mutter.
References
  1. K. Krogh, P.Christensen, S. Sabroe, S. Laurberg. Neurogenic bowel dysfunction score. Spinal Cord (2006) 44: 625-631
Disclosures
Funding none Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics not Req'd procedure was already approved Helsinki Yes Informed Consent Yes