Assessment of Longterm Ureteral Stenting

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02871609
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Longterm Indwelling Ureteral Stent	Other: Stent examination, urinary analysis, USSQ questionnaire

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Longterm Ureteral Stenting: Assessment of Stent- Associated Morbidity, Associated Costs and Impact of Biofilms
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients with longterm ureteral stent	Other: Stent examination, urinary analysis, USSQ questionnaire

Outcome Measures

Primary Outcome Measures

1. Total biofilm mass on ureteral stents [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) [Day of stent removal/change: three months (range 2-4 months) after last stent insertion/change]

Secondary Outcome Measures

1. Urine Culture [2-6 months after stent insertion]

2. Number of bacteria on stent surface, if applicable number of bacteria on two indwelling stents [2-6 months after stent insertion]

3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [2-6 months after stent insertion]

4. Assessment of costs arising from complications [2-6 months after stent insertion]

   complications assessed by CTCAE v4.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urological Department, Cantonal Hospital of St. Gallen	St. Gallen		Switzerland

Sponsors and Collaborators

• Cantonal Hospital of St. Gallen

Investigators

• Principal Investigator: Patrick Betschart, Dr. med., Department of Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick Betschart, Dr. med., Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT02871609
• Other Study ID Numbers: CTU 16.011
• First Posted: Aug 18, 2016
• Last Update Posted: Jan 31, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Patrick Betschart, Dr. med., Cantonal Hospital of St. Gallen: Biofilm; Morbidity; Ureteral Catheterization

Study Results

No Results Posted as of Jan 31, 2019