Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Urinary Catheters

Evaluation of a Novel Medical Device to Facilitate Gel Instillation During Change of Long-term Indwelling Urinary Catheters - a Randomized Controlled Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03289117

Enrollment

Registered

2017-09-20

Start date

2016-04-17

Completion date

2017-05-26

Last updated

2017-10-20

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

Conditions

Anesthesia, Local, Incontinence, Urinary, Retention, Urinary, Urinary Catheters

Keywords

Urinary catheterization, Gel installation, Novel medical device, Indwelling urinary catheter, Long-term urinary catheter, Male patients

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).

Interventions

DEVICENovel gel installation device procedure

Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device

DEVICEStandard procedure

Catheter change with standard procedure Each subject will undergo catheter change with standard procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Masking description

Open label

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.

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Treatment duration (min)	During procedure	Treatment duration for procedure

Secondary

Measure	Time frame	Description
Patient's perceived pain (NRS scale)	During intervention	Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)
Number of gel syringes used	During intervention	Number of pre-filled gel syringes used during the procedure

Other

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	During intervention	Incidence of Treatment-Emergent Adverse Events found during procedure

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026