A Study to Determine User Acceptability and Laboratory Data Regarding Use of a Novel Indwelling Urinary Catheter: the Optitip Study

NCT04688541 | Withdrawn

• 1 other identifier: ERGO 53798
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, long-term catheter patients in the Community setting (both catheter clinic attenders or home catheter changes) will be invited to participate in a randomised cross-over study to compare their standard Foley catheter with the Optitip catheter. The participants will be randomised to Arm A (Standard Foley catheter then Optitip) or Arm B (Optitip then Standard Foley catheter) and will have each catheter inserted for successive periods of 4 weeks (+ up to 7 days). The catheters will be collected following removal and analysed for presence of biofilm; catheter specimens of urine will also be collected to measure detection/quantity microorganisms and cytokines. The quality of life of participants will be assessed at baseline and the end of each study period using a validated quality of life tool for long-term catheter users - the ICIQ-LTCqol.

Conditions

Urologic Diseases

Keywords

Catheter; Pilot; Biofilm

Outcome Measures

Primary Outcomes (1)

• Number of blockage - accumulation of biofilm

  To compare the accumulation of biofilm on the catheter surface as a marker for the likelihood of blockage following 4 weeks insertion of an Optitip catheter to 4 weeks insertion of a standard Foley catheter. The 2 catheters (Foley and Optitip) will be collected and sent to the laboratory immediately after removal - the insertion period is 4 weeks + up to 7 days.

  4 weeks + up to 7 days.

Secondary Outcomes (3)

• Participant completion of the validated quality of life tool - ICIQ-LTCqol.

  56 days (+ up to 14 days)

• Quantify microorganisms in the urine.

  56 days (+ up to 14 days)

• Quantify cytokines in the urine.

  56 days (+ up to 14 days)

Study Arms (2)

First standard Foley catheter than Optitip catheter

ACTIVE COMPARATOR

Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Standard Foley catheter Study period 2 = Optitip catheter

Device: Optitip Catheter (LinC Medical); Device: Foley catheter

First Optitip catheter than standard Foley catheter

ACTIVE COMPARATOR

Each participant is given the 2 trial catheters for successive periods of 4 weeks (+ up to 7 days) for each treatment period: Study period 1 = Optitip catheter Study period 2 = Standard Foley catheter

Device: Optitip Catheter (LinC Medical); Device: Foley catheter

Interventions

Optitip Catheter (LinC Medical) DEVICE

The Optitip catheter, unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.

First Optitip catheter than standard Foley catheter; First standard Foley catheter than Optitip catheter

Foley catheter DEVICE

Foley catheter

First Optitip catheter than standard Foley catheter; First standard Foley catheter than Optitip catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Existing patients of Solent NHS Trust for \> 3months
• Capable of giving informed consent
• Adult men or women (≥18)
• Planning to be using a long-term catheter for the duration of the study (3 months)
• Able to attend the clinic on the clinic/research days for catheter changes or have a research nurse visit them at home to do the changes
• Willing to have the next 2 catheter changes at 4 weekly intervals, which may be different from their usual change interval

You may not qualify if:

• Currently pregnant or planning to become pregnant
• Lack of capacity to consent
• Currently taking antibiotics for any reason (not just UTI) - unless the patient is usually on long term prophylactic antibiotics they may continue as long as they do so for the duration of the trial (unless instructed otherwise by a medical professional)
• Taken antibiotics for any reason in the previous month
• Has frequent catheter blockage ie. requiring catheter changes usually less than 4 weekly or visits for other catheter related reasons more frequently than 4 weekly
• Planned bladder washouts of any frequency
• Suprapubic catheter users
• Those who need to visit a urology clinic due to complex catheter changes
• Participation in a related study
• Using a non-standard catheter e.g. not a Foley design
• Using an unusual sized catheter - outside the sizes available (12-18F)
• Unable to complete the assessments in English

Sponsors & Collaborators

• University of Southampton: lead

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mandy Fader

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: December 30, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 14, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share