Trial Outcomes & Findings for Exploratory Study Investigating Urodynamic Parameters During Catheterisation (NCT NCT03337048)

Results Overview

On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Filled out after 5 minutes per catheterisation.

Results posted on

2024-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Volunteers 10 healthy volunteers	Spinal Cord Injury (SCI) 10 spinal cord injured patients	Benign Prostate Hyperplasia 10 benign prostate hyperplasia patients
Overall Study STARTED	10	10	10
Overall Study COMPLETED	8	10	10
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Volunteers 10 healthy volunteers	Spinal Cord Injury (SCI) 10 spinal cord injured patients	Benign Prostate Hyperplasia 10 benign prostate hyperplasia patients
Overall Study Withdrawal by Subject	2	0	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Urodynamic Parameters During Catheterisation n=30 Participants Exploratory measurements of Urodynamic parameters
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=30 Participants
Age, Categorical >=65 years	10 Participants n=30 Participants
Sex: Female, Male Female	0 Participants n=30 Participants
Sex: Female, Male Male	30 Participants n=30 Participants
Region of Enrollment Denmark	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: Filled out after 5 minutes per catheterisation.

Population: 8 healthy volunteers, 10 subjects with spinal cord injury and 10 subjects with enlarged prostate

On a scale ranging from 0 "no discomfort" to 10 "worst possible discomfort" caused by the catheter, set a vertical line indicating how you experienced the insertion of the catheter. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Measurement of Endpoints n=28 Participants In healthy volunteers the endpoint are measured while spontaneous voiding of the bladder and while emptying the bladder using a standard intermittent catheter (SpeediCath). In subjects with spinal cord injury or enlarged prostata the endpoint are measured while emptying the bladder using a standard intermittent catheter. SpeediCath: SpeediCath is a standard intermittent catheter that is on the market.
Discomfort During Catheter Insertion on a Visual Analogue Scale healthy volunteers	1.2 score on a scale Interval 0.1 to 3.9
Discomfort During Catheter Insertion on a Visual Analogue Scale Spinal Cord Injury	1.0 score on a scale Interval 0.0 to 6.1
Discomfort During Catheter Insertion on a Visual Analogue Scale Benign prostatic hyperplasia	1.1 score on a scale Interval 0.0 to 2.6

Adverse Events

Measurement of Endpoints

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President, Medical Affairs

Coloplast A/S

Phone: +45 49111111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60