Trial Outcomes & Findings for Intermittent Catheterization in Spinal Cord Injured Men (NCT NCT02230540)

Results Overview

The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume \<100ml" to "collected volume \> 200ml", were used to interpret the primary endpoint.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

2-4 hours

Results posted on

2016-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence A Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions. Measurement of residual urine at different positions. SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage. Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).	Sequence B Based on results from sequence A, sequence B may or may not be initiated. Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product B in different positions. Measurement of residual urine at different positions. SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage. Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
Overall Study STARTED	8	0
Overall Study COMPLETED	8	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Catheterization in Spinal Cord Injured Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence A n=8 Participants Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions and measurement of residual urine. SelfCath (comparator): Catheter for urinary drainage. Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Denmark	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-4 hours

The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat. Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly. Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume \<100ml" to "collected volume \> 200ml", were used to interpret the primary endpoint.

Outcome measures

Outcome measures
Measure	Sequence A n=8 Participants Catheterization with SelfCath (comparator) followed by measurement of residual urine. Then catheterization with Product A in different positions and measurement of residual urine. SelfCath (comparator): Catheter for urinary drainage. Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Residual Volume Less Than 100ml Height 25cm	6 Subjects with successful catheterization
Residual Volume Less Than 100ml Height 20cm	6 Subjects with successful catheterization
Residual Volume Less Than 100ml Height 15cm	6 Subjects with successful catheterization
Residual Volume Less Than 100ml Height 10cm	6 Subjects with successful catheterization
Residual Volume Less Than 100ml Height 0cm	7 Subjects with successful catheterization

Adverse Events

Sequence A

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

Per Bagi, MD

Rigshospitalet, Department of Urology

Phone: +45 3545 8310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigators who want to publish/present results based on own data from a Coloplast-sponsored investigation, must send the publication/presentation to sponsor for review 60 days prior to submission. Sponsor reserves the right to delay publications to avoid compromising intellectual property. Publications of sub-analyses may be delayed by sponsor until main results of investigation have been published.
Publication restrictions are in place

Restriction type: OTHER