An interventional study of Novel gel installation device procedure and Standard procedure in Urinary Catheters, Retention, Urinary and Incontinence, Urinary, sponsored by Region Skane. Completed at 1 site in Sweden. Open to male participants. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Region Skane · Not applicable, Interventional, and Supportive care
A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 32 is below the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure
Device: Novel gel installation device procedure
Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure
Device: Standard procedure
Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
Catheter change with standard procedure Each subject will undergo catheter change with standard procedure
Treatment duration (min)
Treatment duration for procedure
Time frame: During procedure
Patient's perceived pain (NRS scale)
Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)
Time frame: During intervention
Number of gel syringes used
Number of pre-filled gel syringes used during the procedure
Time frame: During intervention
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events found during procedure
Time frame: During intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2016 to primary completion in May 2017, 13 months.
Of 70 non-industry interventional studies with no phase under Urinary Retention, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 82 studies reached it within 18 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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