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NCT05065255: Eva
Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization
trial testing SpeediCath® catheters in Urinary Retention in 250 participants. Status unknown.
30 January 2023
Quick facts
| Lead sponsor | Laboratoires Coloplast S.A.S |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 30 September 2021 |
| Primary completion | 30 January 2023 |
| Estimated completion | 30 January 2023 |
| Sites | 38 locations across France |
Drugs / interventions tested
- SpeediCath® catheters
Conditions studied
- Urinary Retention — all drugs for Urinary Retention →
Sponsor
Laboratoires Coloplast S.A.S
Who can join
18 and older, any sex, with Urinary Retention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date, there is no objective data to help in the choice of the type of catheter to offer to the patient according to his or her needs. Although it is now known that the quality of life of patients practicing intermittent self catheterisation is dependent on multiple factors, there is little data on the factors that facilitate or hinder adherence to intermittent self catheterisation during the first six months after initiation of intermittent self catheterisation. The prospective multicenter exploratory observational study that the sponsor wishes to conduct aims to determine what criteria preside over patient choice of SpeedyCath (SC) leads. This information would allow us to set up a personalized advice with each patient in the future, with the aim of proposing the SC catheter best adapted to his needs. The study population will consist of adults with neurogenic or non-neurogenic urinary disorders that warrant the use of intermittent self catheterisation, with intermittent self catheterisation education occurring at the time of inclusion. Patients should be autonomous in the practice of intermittent self catheterisation, and the minimum expected duration of follow-up should be greater than or equal to 6 months. Only patients who choose to use SpeediCath leads will be included in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05065255
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Other Laboratoires Coloplast S.A.S trials
Trials by the same sponsor.
- NCT04635215 — Observational Study of the Quality of Life of New Ostomates Using SenSura Mio Appliances With BodyFit Technology · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05065255 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratoires Coloplast S.A.S
- Last refreshed: 11 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05065255.
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