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Analysis of the TrueClr external catheter’s effectiveness in emptying the bladder

TrueClr Sweden pilot study 2023-01

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78009485
Enrollment
25
Registered
2023-06-28
Start date
2023-06-20
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urology (urine retention) Urological and Genital Diseases

Interventions

The TrueClr External Catheter will be applied to the penises of participating subjects, after which the aspirator will be activated to apply suction to the penis. The TrueClr will remain applied for 1

Sponsors

Mareld Medical AB
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients aged 18 years and over benefitting from the use of a urinary catheter

Exclusion criteria

Exclusion criteria: Urethral stricture or other conditions negating the efficacy of an external urinary catheter

Design outcomes

Primary

MeasureTime frame
The TrueClr external catheters' efficacy in emptying the bladder will be measured by recording the volume of urine collected. Extracted urine volume is measured in mL after the intervention.

Secondary

MeasureTime frame
1. Patient satisfaction levels with safety and comfort recorded on a Visual Analogue Scale, with levels ranging from 1-10 (1 being extremely unsatisfied and 10 being extremely satisfied), after the intervention 2. Medical professional satisfaction levels with safety and comfort recorded on a Visual Analogue Scale, with levels ranging from 1-10 (1 being extremely unsatisfied and 10 being extremely satisfied), after the intervention

Countries

Sweden

Contacts

Public ContactOscar Larsson
oscar@mareldmedical.com+46 (0)768326260

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026