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Clinical Trials/ISRCTN68472863
ISRCTN68472863
Terminated
未知

Development and Clinical Trial of a Mixed (Multi/Single-use) Catheter Management Package for Users of Intermittent Catheterisation (The MultICath Study)

niversity of Southampton0 sites500 target enrollmentMarch 10, 2016
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ConditionsTopic: Primary Care, RenalSubtopic: Primary Care (Renal Disorders), Renal (Renal Disorders)Disease: All Diseases, All Renal DisordersUrological and Genital DiseasesCatheterisation

Overview

Phase
未知
Intervention
Not specified
Conditions
Topic: Primary Care, Renal
Sponsor
niversity of Southampton
Enrollment
500
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 10, 2016
End Date
March 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Southampton

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 16 years and over
  • •2\. Intermittent catheterisation planned to continue for 12 months
  • •3\. Able and willing to adhere to a 12\-month follow up period
  • •4\. Currently using or preparing to start using intermittent catheterisation (via the urethra), performed by self or sole carer
  • •5\. Patient has provided written informed consent for participation in the study prior to any study specific procedures

Exclusion Criteria

  • •1\. Aged below 16 years
  • •2\. Use of IC for self\-dilatation of urethral stricture (ISD) without bladder drainage
  • •3\. Non\-urethral route for catheterisation e.g. Mitrofanoff
  • •4\. External carer required for IC (i.e. where sterile technique and catheter is required e.g. visiting community nurse performs IC)
  • •5\. Inability to give informed consent or have primary outcome information collected
  • •6\. Women who are pregnant, planning to become pregnant or breast feeding during the trial

Outcomes

Primary Outcomes

Not specified

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