Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Longterm Indwelling Ureteral Stent
- Sponsor
- Cantonal Hospital of St. Gallen
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Total biofilm mass on ureteral stents
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Patrick Betschart
Dr. med.
Cantonal Hospital of St. Gallen
Eligibility Criteria
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
Outcomes
Primary Outcomes
Total biofilm mass on ureteral stents
Time Frame: 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)
Time Frame: Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change
Secondary Outcomes
- 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)