N/A N=16 Randomized Single-blind Prevention

Investigation of Non-CE Marked Intermittent Catheters.

Retention, Urinary

Bottom Line

View on ClinicalTrials.gov: NCT04543136 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Residual Urine at 1st Flow-stop During Nurse Catheterization — 59.4; 13.1; 0.4 mL — p=0.074

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SpeediCath® Standard male (Device); New intermittent Variant 1 catheter for males (Device); New intermittent Variant 2 catheter for males (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Coloplast A/S
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Residual Urine at 1st Flow-stop During Nurse Catheterization	59.4; 13.1; 0.4	0.074
PRIMARY Residual Urine at 1st Flow-stop During Self-catheterization	61.8; 5.7; 0.0	0.030 sig
SECONDARY Post-void Residual Urine After Nurse Catheterization	24.6; 36.4; 12.7	0.281
SECONDARY Post-void Residual Urine After Self-catheterization	33.9; 29.0; 27.0	0.787
SECONDARY Insertion Discomfort During Nurse Catheterization	0.59; 0.66; 1.20	0.766
SECONDARY Urination Discomfort During Nurse Catheterization	0.44; 0.22; 0.17	0.213
SECONDARY Withdrawal Discomfort During Nurse Catheterization	0.41; 0.32; 0.59	0.661
SECONDARY Overall Discomfort During Nurse Catheterization	0.66; 0.79; 0.72	0.701
SECONDARY Insertion Discomfort During Self-catheterization	0.24; 0.53; 0.73	0.309
SECONDARY Urination Discomfort During Self-catheterization	0.17; 0.18; 0.34	0.896
SECONDARY Withdrawal Discomfort During Self-catheterization	0.15; 0.21; 0.55	0.802
SECONDARY Overall Discomfort During Self-catheterization	0.16; 0.38; 0.72	0.525

Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Eligibility Criteria

Inclusion Criteria

Male
Minimum 18 years of age and with full legal capacity
Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
Ability to self-catheterize
Written informed consent, signed letter of authority and signed secrecy agreement given

Exclusion Criteria

Participation in any other clinical study during this investigation
Symptoms of urinary tract infection as judged by the investigator
Any know allergies towards ingredients in the products
Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04543136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.