Trial Outcomes & Findings for An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization (NCT NCT05626686)

Last Updated: 2024-04-15

Results Overview

The Intermittent Self-Catheterization Questionnaire is a validated, self-reported questionnaire which is scored on a 5-point Likert scale and is translated to a value ranging from 0 (strongly disagree) to 4 (strongly agree) with higher values corresponding to greater Health-related Quality of Life. The aggregate scores across domains and the total score are calculated by averaging and multiplying by 25 to achieve a 100-point scale. Change = (Termination score - Baseline score)

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Baseline (day 0) and Termination (day 28).

Results posted on

2024-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	CLINY Reusable Catheter Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Overall Study STARTED	39
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	CLINY Reusable Catheter Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CLINY Reusable Catheter n=33 Participants Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Age, Continuous	59.7 years STANDARD_DEVIATION 11.1 • n=33 Participants
Sex: Female, Male Female	14 Participants n=33 Participants
Sex: Female, Male Male	19 Participants n=33 Participants
Region of Enrollment Denmark	33 participants n=33 Participants
Height, Continuous	175.3 Centimeters STANDARD_DEVIATION 10.0 • n=33 Participants
Weight, Continuous	81.5 Kilograms STANDARD_DEVIATION 17.3 • n=33 Participants
Reason for IC use, Categorical Spinal Cord Injury	4 Participants n=33 Participants
Reason for IC use, Categorical Multiple Sclerosis	8 Participants n=33 Participants
Reason for IC use, Categorical Benign Prostatic Hyperplasia	4 Participants n=33 Participants
Reason for IC use, Categorical Poor bladder emptying	11 Participants n=33 Participants
Reason for IC use, Categorical Other	6 Participants n=33 Participants
Right hand function, Categorical Normal dexterity	29 Participants n=33 Participants
Right hand function, Categorical Reduced dexterity	4 Participants n=33 Participants
Left hand function, Categorical Normal dexterity	25 Participants n=33 Participants
Left hand function, Categorical Reduced dexterity	6 Participants n=33 Participants
Left hand function, Categorical Do not know	2 Participants n=33 Participants
Urethral Sensitivity, Categorical Impaired	4 Participants n=33 Participants
Urethral Sensitivity, Categorical Normal	24 Participants n=33 Participants
Urethral Sensitivity, Categorical None	5 Participants n=33 Participants
Time since starting IC as bladder management method, Continuous (years)	9.2 years STANDARD_DEVIATION 10.4 • n=33 Participants

PRIMARY outcome

Timeframe: Baseline (day 0) and Termination (day 28).

Population: The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing).

Outcome measures

Outcome measures
Measure	CLINY Reusable Catheter n=33 Participants Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. Baseline visit	79.09 score on a scale Interval 73.69 to 84.49
Change in Health-related Quality of Life From Baseline (Visit 1) to Termination (Visit 5), Measured by the Intermittent Self-Catheterization Questionnaire Index Score. Termination visit	56.66 score on a scale Interval 51.26 to 62.06

SECONDARY outcome

Timeframe: 28 days

Population: The full analysis set constituted all subjects enrolled who had been exposed to at least one device, with at least one endpoint recorded (data non-missing).

Number of Adverse Events during the study

Outcome measures

Outcome measures
Measure	CLINY Reusable Catheter n=33 Participants Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Adverse Events	11 Adverse events

Adverse Events

CLINY Reusable Catheter

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CLINY Reusable Catheter n=39 participants at risk Subjects used the reusable CLINY catheter for 28 days, replacing their regular use of single-use catheters.
Renal and urinary disorders Blood in urine	12.8% 5/39 • Number of events 5 • 28 days
Renal and urinary disorders Urinary Tract Infection	10.3% 4/39 • Number of events 4 • 28 days
Renal and urinary disorders Tears in the urethra	2.6% 1/39 • Number of events 1 • 28 days
Renal and urinary disorders Pain in urinary tract	2.6% 1/39 • Number of events 1 • 28 days

Additional Information

Zenia Størling, Senior Director of Clinical Strategies

Coloplast

Phone: +4549111869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60