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

Region Skane32 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Urinary Catheters Retention, Urinary Incontinence, Urinary Anesthesia, Local

Interventions

Novel gel installation device procedureDEVICE

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

Standard procedureDEVICE

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

Skåne University Hospital - Urology clinic - Homecare unit

Lund, Sweden

Outcomes

Primary Outcomes

Treatment duration (min)

Treatment duration for procedure

Time frame: During procedure

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.