N/A N=15 Randomized Single-blind Prevention

Investigation of Non-CE Marked Intermittent Catheters for Females

Retention, Urinary

Bottom Line

View on ClinicalTrials.gov: NCT04557787 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Residual Urine at 1st Flow-stop During Nurse Catheterization — 28.6; 0.0; 0.0 mL — p=0.001

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Residual Urine at 1st Flow-stop During Nurse Catheterization	28.6; 0.0; 0.0	0.001 sig
PRIMARY Residual Urine at 1st Flow-stop During Self-catheterization	33.7; 0.3; 3.6	<0.001 sig
SECONDARY Post-void Residual Urine After Nurse Catheterization	2.8; 6.7; 2.8	0.503
SECONDARY Post-void Residual Urine After Self-catheterization	0; 0; 9.1	0.955
SECONDARY Insertion Discomfort During Nurse Catheterization	0.48; 0.29; 0.48	0.352
SECONDARY Urination Discomfort During Nurse Catheterization	0.47; 0.58; 0.17	0.700
SECONDARY Withdrawal Discomfort During Nurse Catheterization	1.61; 0.59; 0.82	0.013 sig
SECONDARY Overall Discomfort During Nurse Catheterization	1.00; 0.53; 0.39	0.027 sig
SECONDARY Insertion Discomfort During Self-catheterization	0.53; 0.38; 0.21	0.461
SECONDARY Urination Discomfort During Self-catheterization	0.45; 0.27; 0.41	0.478
SECONDARY Withdrawal Discomfort During Self-catheterization	1.29; 0.39; 0.34	0.030 sig
SECONDARY Overall Discomfort During Self-catheterization	0.77; 0.40; 0.37	0.084

Summary

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

Eligibility Criteria

Inclusion Criteria

Female
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

Breastfeeding
Pregnancy (based on pregnancy test - urine)
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 (investigators judgement)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04557787). 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.