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Completed

NCT Number: NCT03289117

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

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.

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Key information

Conditions

Urinary Catheters Anesthesia, Local Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence, Urinary Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Retention, Urinary Signs and Symptoms Urinary Incontinence Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Skåne University Hospital - Urology clinic - Homecare unit

Lund, 22185, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel gel installation device procedure

Device

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

Standard procedure

Device

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

Primary outcomes

  1. Treatment duration (min)

    Time frame: During procedure

    Treatment duration for procedure

Secondary outcomes

  1. Patient's perceived pain (NRS scale)

    Time frame: During intervention

    Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale)

  2. Number of gel syringes used

    Time frame: During intervention

    Number of pre-filled gel syringes used during the procedure

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: During intervention

    Incidence of Treatment-Emergent Adverse Events found during procedure

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Innovation Skåne AB/ Sweden
  • Lund University
  • Vinnova

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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