Clinical Evidence

Read about clinical evidence on the Peristeen® bowel irrigation system and products such as intermittent catheters and clean self-catheterization.

Bowel irrigation system

Clinical evidence on Peristeen® Peristeen® delivers proven clinical improvement in bowel management of neurogenic patients. More than 1,000 patients have evaluated the treatment modality. Get to know more about the results
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A study on the transanal irrigation system

References

  1. Christensen P et al. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal-cord injured patients. Gastroenterology 2006;131:738-747.3.
  2. Faaborg PM et al. Long-term outcome and safety of transanal colonic irrigation for neurogenic bowel dysfunction. Spinal Cord 2009;47:545-549.4.
  3. Emmanuel A. Review of the efficacy and safety of transanal irrigation for neurogenic bowel dysfunction. Spinal Cord 2010;48:664-673.

Many clinical studies and reviews have been published on transanal irrigation and the use of Peristeen. More than 1,000 patients have evaluated the treatment modality. Peristeen reduces symptoms of constipation and fecal incontinence. A large randomized controlled trial investigated the efficacy and safety of Peristeen compared to conservative bowel management treatment - defined as adjustment in diet and fluid, regular activity and use of laxatives or constipating medication(1).

Figure 1 and 2: A significant reduction in constipation symptoms and faecal incontinence symptomswhen using Peristeen compared to conservative treatment.

Fig. 1: A significant reduction in constipation symptoms from13.2 to 10.3 when using Peristeen compared to conservative treatment.

Fig. 2: A significant reduction in faecal incontinence symptoms from 7.3 to 5.0 when using Peristeen compared to conservative treatment.

 

Peristeen is proven to be safe in use

Figure 3 and 4: Using Peristeen reduces the time spent on bowel emptying significantly and is proven to be safe.

Fig. 3: Time spent on bowel management was reduced from74.4 to 47.0 minutes when using Peristeen (2).

Fig. 4: List of side-effects when using Peristeen (3).

  • Minor side effects were reported in 48% of patients in a long-term study
  • One non-lethal bowel perforation occurred in ~ 50,000 irrigations
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NBD score: A useful tool in your practice A a symptom-based tool to help identify those patients who may benefit from using Peristeen for transanal irrigation. Read more and download the NBD score
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NBD score - The Neurogenic Bowel Dysfunction score

References

  1. Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord 2006;44:625–631

The Neurogenic Bowel Dysfunction (NBD) score is a recently developed, validated questionnaire to assess the impact of colorectal symptoms on patients’ quality of life(1).

The questionnaire could is also be useful to assess any change in the patient’s condition when tested 2–3 months after the initiation of colonic irrigation. This in turn could improve patient adherence to treatment.

This questionnaire is simple to use and can be self-administered by individual patients. It contains 10 questions; giving a total score of between 0 and 47,corresponding to the severity of colorectal disorders experienced. A score ≥10 corresponds to moderate to severe bowel dysfunction and would justify the use of Peristeen.

We hope the NBD score will be a useful tool in your practice.

Download and print the questionnaire.

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Intermittent catheters

Summary of evidence of hydrophilic coated catheters Intermittent catheterization (IC) is the standard method for bladder emptying in patients with spinal cord lesions and neurogenic bladder dysfunction. More on hydrophilic coated catheters
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Table of contents

References

  1. Hedlund et al, 2001

In this summary you will find clinical evidence with on:

  1. Clean Intermittent Self-Catheterization
  2. Urinary Tract Infections
  3. Urethral Trauma
  4. User evaluations

Download the full report (pdf, 3,976 KB)

 

1. Clean Intermittent Self-Catheterization:

  • Clean intermittent self-catheterization: a 12-year follow-up
  • Clean intermittent catheterization from the acute period in spinal cord injury patients. 
  • Long-term evaluation of urethral and genital tolerance.
  • Effect of bladder management on urological complications in 10 spinal cord injured patients.


2. Urinary Tract Infections:

  • Hydrophilic versus non-coated catheters for intermittent catheterization. 
  • Complications of intermittent catheterization: their prevention and treatment. 
  • Intermittent catheterization with hydrophilic-coated catheters (SpeediCath) reduces the risk of clinical urinary tract infection in spinal cord injured patients: a prospective randomized parallel comparative trial.
  • Standard versus hydrophilic catheterization in the adjuvant treatment of patients with superficial bladder cancer.
  • Intermittent catheterization with a hydrophilic-coated catheter delays the occurrence of urinary tract infection in patients with acute spinal cord injury: A prospective, randomized, parallel, multi-center trial.


3. Urethral Trauma:

  • Complications of intermittent catheterization: their prevention and treatment.
  • Urethral epithelial cells on the surface on hydrophilic catheters after intermittent catheterization: cross-over study with two catheters.
  • Coated catheters for intermittent catheterization: smooth or sticky? 
  • Hydrophilic-coated catheters for intermittent catheterization reduce urethral micro trauma: a prospective, randomized, participant-blinded, crossover study of three different types of catheters.
  • Safety of a new compact male intermittent catheter: a randomized, cross-over, single blind study in healthy male volunteers.
  • Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomized, cross-over, open-labelled study.


4. User evaluations on:

  • Pain & discomfort
  • Ease of use

 

Download the full report (pdf, 3,976 KB)

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SpeediCath Product Monograph Intermittent catheterization is considered the standard of care for bladder emptying. Coloplast has developed the SpeediCath range of ready-to-use hydrophilic-coated catheters. SpeediCath Product Monograph
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Table of contents

In this monograph you can learn about:

  1. Management of neurogenic bladder with urethral intermittent catheterization
  2. Intermittent catheterization technique and long-term concordance
  3. Key features of the SpeediCath family
  4. The SpeediCath catheter range
  5. Evidence from clinical studies of SpeediCath
  6. Environment

Download the full report (pdf, 1 MB)

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