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Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction

NCT00913510 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-11

Study results available
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Summary

The aims of this prospective, randomized study are:

* To assess the effect of clean intermittent catheterization (CIC)
* To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs
* To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL
* To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients

Conditions

Interventions

DEVICE

CIC using LoFric Primo

Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, and start of CIC using LoFric Primo catheters, i.e. Drug + Device.

DRUG

Anticholinergic medication

Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start, i.e. Drug.

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Clare Fowler, Prof. · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Belgium
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913510 on ClinicalTrials.gov