Feasibility Assessment of ACS Catheter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

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This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.

The study will examine the safety and performance of a new urinary catheter, the Alternative Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which has been developed to reduce the morbidity of long-term catheterisation and the acknowledged deficiencies of the conventional Foley urinary catheter.

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Detailed Description

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Conditions

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Urological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Catheter placed

Group Type EXPERIMENTAL

ACS Catheter

Intervention Type DEVICE

Interventions

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ACS Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female, at least 18 years of age.
2. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
3. Capable of using a catheter valve to empty the bladder and able to communicate their experience with the system OR who has a carer able to fulfil these tasks.
4. Fitted with a suprapubic catheter (at least 2 weeks post insertion).
5. Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
6. History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months.

Exclusion Criteria

1. \<18 years of age.
2. Pregnant or lactating females.
3. History of catheter associated septicaemia in the past month.
4. Evidence of current systemic infection.
5. Bladder pathology such as a tumour or stone \>0.5cm as determined by cystoscopy.
6. Flaccid bladder.
7. BMI\>35.
8. Current participation in another device or drug study.
9. Unwilling or unable to provide informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No