Assessment of Longterm Ureteral Stenting

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02871609

Enrollment

Registered

2016-08-18

Start date

2016-07-31

Completion date

2018-11-30

Last updated

2019-01-31

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

Conditions

Longterm Indwelling Ureteral Stent

Keywords

Biofilm, Morbidity, Ureteral Catheterization

Brief summary

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

Detailed description

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.

Interventions

OTHERStent examination, urinary analysis, USSQ questionnaire

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total biofilm mass on ureteral stents	Time of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)	Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change

Secondary

Measure	Time frame	Description
Urine Culture	2-6 months after stent insertion	—
Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents	2-6 months after stent insertion	—
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	2-6 months after stent insertion	—
Assessment of costs arising from complications	2-6 months after stent insertion	complications assessed by CTCAE v4.0

Countries

Switzerland

Outcome results

None listed

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