N/A N=43 Randomized Prevention

Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter

Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT05224544 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale. — 0.84; 0.76 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Investigational prototype device (Device); Comparator device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Coloplast A/S
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.	0.84; 0.76	—

Summary

This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator (PI), or designee. Each subject were enrolled in the investigation, which lasted up to 3 days (if Day 0 and Day 1 were not on same day). The subjects were randomly assigned to test either the prototype product or the comparator product, with at least 20 subjects assigned to each product.

Eligibility Criteria

Inclusion Criteria

Has given written informed consent
Is at least 18 years and have full legal capacity
Is female
Has a negative urine Multistix dipstick test for erythrocytes (haematuria)

Exclusion Criteria

Has used an internal urinary catheter or cystoscopy within the past month
Has prior history of bladder surgery
Is symptomatic and/or on medication for overactive bladder
Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
Is pregnant and/or breast-feeding
Is participating in other clinical investigations during this investigation
Is menstruating during study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05224544). 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.