Clinical trial NCT03289117: Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters
Official title: Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Catheters
Retention, Urinary
Incontinence, Urinary
Anesthesia, Local
Keywords: Urinary catheterization
Gel installation
Novel medical device
Indwelling urinary catheter
Long-term urinary catheter
Male patients
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Vinnova
name: Innovation Skåne AB/ Sweden
First posted: 2017-09-20
Enrollment: 32
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device.

Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* The patient has an indwelling catheter and a primary diagnosis that justify continued catheter use
* The patient provides informed consent prior to any study specific procedures
* The patient is considered to benefit from participation in the clinical study

Exclusion Criteria:

* The patient do not consent to participate in the study
* Trauma to urethra or bladder
* Infection to urethra or bladder
* Other diagnosis that contraindicates participation in the clinical study as judged by the responsible physician

Primary outcomes:
measure: Treatment duration (min)
timeFrame: During procedure
Secondary outcomes:
measure: Patient's perceived pain (NRS scale)
timeFrame: During intervention
measure: Number of gel syringes used
timeFrame: During intervention
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: During intervention
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital - Urology clinic - Homecare unit
Study officials:
affiliation: Clinical Studies Sweden - Forum South
name: Ulf Malmqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: