New Coating for Urinary Intermittent Catheters

Last updated: May 21, 2025
Sponsor: Coloplast A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Genitourinary Prolapse

Treatment

SpeediCath® Standard male

SpeediCath® Standard male new coating

Clinical Study ID

NCT06985888
CP372
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study Summary

The goal is to confirm, that the newly developed coating is non-inferior to the comparator with respect to the overall discomfort of the catheterisation (assessed by participant).

Participants will attend 3 study site visits and will be catheterised by a HCP at visit 1 and 2 with one of the two catheters in randomisation order. Urine samples will be collected pre- and post catheterisation for assessments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has given written informed consent

  2. Is at least 18 years old

  3. Has full legal capacity

  4. Has self-assessed intact male anatomy with no abnormalities or disease of the lowerurinary tract or any surgical procedures performed in the lower urinary tract

  5. Is able (assessed by investigator) and willing to adhere to study procedures duringstudy duration.

  6. Is able to refrain from using analgesics up to 24 hours prior to catheterisationvisits

  7. Is negative for haematuria, measured by urine dipstick test of erythrocytes

Exclusion

Exclusion Criteria:

  1. Is participating in any other clinical investigation during this investigation,which could affect the results of this investigation, as assessed by investigator.

  2. Has previously been randomized in this investigation.

  3. Has known hypersensitivity towards any of the devices used in the investigation

  4. Is currently experiencing symptoms associated with UTI, as assessed by investigator.

  5. Has known impaired sensation of the urethra

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: SpeediCath® Standard male
Phase:
Study Start date:
May 06, 2025
Estimated Completion Date:
August 31, 2025

Study Description

The primary objective of the study is to confirm that the newly developed investigational coating is non-inferior to the comparator coating with respect to the overall discomfort of catheterisation.

The investigational device is a ready-to-use, sterile, hydrophilic-coated Nelaton male catheter for intermittent catheterisation and based on the standard SpeediCath® male intermittent catheter with a difference in the composition on the coating.

The study is a double-blinded, randomized, crossover study including 32 randomized healthy male volunteers. The total study duration for the individual subject will be between 4-21 days and consists of 3 site visits V0, V1 and V2, and V0 andV1 can be combined

At V1 and V2 the subjects will be catheterized in a hospital setting by a health care professional, with one of the two catheters in a randomized order. Subject will be asked to assess the overall discomfort of the catheterisation on VAS.

Connect with a study center

  • Department of Urology, Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.