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OpenTrials
Completed

NCT Number: NCT02871609

Assessment of Longterm Ureteral Stenting

This study is performed to analyze various aspects of biofilms on ureteral stents in a longterm setting.

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Key information

Conditions

Longterm Indwelling Ureteral Stent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

About this study

The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity in a longterm setting.

In addition, the trial is intended to give an overview of the incidence of complaints, the occurrence of complications and their economic aspects.

The influence of biofilms on the morbidity associated with longterm ureteral stenting is assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with longterm indwelling ureteral stent (minimum of 2 months) undergoing regular changes
  • Informed consent
  • responsible patients

Exclusion criteria

  • ongoing therapy: OAB, LUTS, urinary incontinence, chronic prostatitis, chronic pelvic pain syndrome
  • insufficient language skills
  • cognitive limitation

Treatment and study plan

Stent examination, urinary analysis, USSQ questionnaire

Other

Primary outcomes

  1. Total biofilm mass on ureteral stents

    Time frame: Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change

  2. Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)

    Time frame: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change

Secondary outcomes

  1. Urine Culture

    Time frame: 2-6 months after stent insertion

  2. Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents

    Time frame: 2-6 months after stent insertion

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 2-6 months after stent insertion

  4. Assessment of costs arising from complications

    Time frame: 2-6 months after stent insertion

    complications assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2016
Registry last updated
Jan 31, 2019

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.