Performance of a Single-use Intermittent Micro-hole Zone Catheter

Urinary Incontinence Clinical Trial

Official title:

A Randomized, Open-labelled, Crossover Study Confirming Performance of a Single-use Intermittent Micro-hole Zone Catheter in a Population of Adult Male Intermittent Catheter Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485922
• Other study ID #: CP353
• Status: Completed
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: November 4, 2022

Study information

• Verified date: December 2022
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.

The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Description:

The investigation was a single-centre, randomized, controlled crossover study including 42 male IC users comparing the performance of two intermittent catheters.

The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is Male

2. Is at least 18 years of age and has full legal capacity

3. Has given written informed consent

4. Has signed letter of authority (only DK)

5. Has used clean intermittent catheterisation CH12 or CH14 for at least one month

6. Use intermittent catheterisation as the primary bladder emptying method

7. Is able (assessed by investigator) and willing to follow study procedures

Exclusion Criteria:

1. Is participating in any other clinical study during this investigation

2. Has previous participated in this study

3. Has symptoms of urinary tract infection as judged by the investigator 4 Is an individual with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris

5. Has any known allergies towards ingredients in the investigational device

Related Conditions & MeSH terms

• Retention, Urinary
• Urinary Incontinence
• Urinary Retention

Intervention

Device:
• Investigational device - intermittent catheter with a micro-hole zone
The investigational device was a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.
• Comparator device -VaPro intermittent catheter
The comparator device is a urinary catheter for bladder drainage through the urethra. The product is for intermittent use.

Locations

Country	Name	City	State
Denmark	Sanos Clinic	Gandrup

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-stop episodes	Flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying.; From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec).; Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.	Immediately after the procedure/catheterization, up to 5min
Primary	Residual urine	The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.; Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].	Immediately after the procedure/catheterization, up to 5min