Feasibility Assessment of ACS Catheter

A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01960517

Acronym

ACS1

Enrollment

Registered

2013-10-10

Start date

2014-01-31

Completion date

2014-05-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological

Keywords

Urinary, Incontinence, Catheter

Brief summary

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.

Interventions

DEVICEACS Catheter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Retention of the ACS catheter	12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026