- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03344120
Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial
December 28, 2020 updated by: Andrea Bosio, Azienda Ospedaliera Città della Salute e della Scienza di Torino
Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies.
Stent-related symptoms (SRS) represent a major issue.
Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance.
To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS.
Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turin, Italy, 10126
- AOU Città della Salute e della Scienza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
- stone-free procedure and absence of intraprocedural complications
- WHO performance status 0-2
Exclusion Criteria:
- significant residual fragments at the end of the procedure
- intraprocedural complications (e.g. ureteral damage or stricture)
- indwelling double J stent
- acute kidney failure
- urinary tract infection
- urinary tract abnormalities
- pathologies or medications potentially influencing voiding pattern and pain perception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: suture stent
suture stent positioning after ureteroscopy.
Intervention: administration of USSQ questionnaire.
|
Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
|
Active Comparator: conventional double-J stent
conventional double-J stent positioning after ureteroscopy.
Intervention: administration of USSQ questionnaire.
|
Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary Symptom Index Score
Time Frame: 14 days
|
to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
USSQ domains' scores
Time Frame: 14 days
|
to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery
|
14 days
|
USSQ domains' scores
Time Frame: 2 days
|
to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery
|
2 days
|
USSQ single answers
Time Frame: 14 day
|
to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery
|
14 day
|
USSQ single answers
Time Frame: 2 days
|
to compare USSQ single answers of suture stent and double J group, 2 days after surgery
|
2 days
|
2 weeks USSQ domains' subscores adjusted for baseline
Time Frame: 6 weeks
|
to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group
|
6 weeks
|
complications and adverse events
Time Frame: 2 weeks
|
to compare complications and adverse events of suture stent and double J group
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea Bosio, Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2020
Primary Completion (Actual)
November 2, 2020
Study Completion (Actual)
December 16, 2020
Study Registration Dates
First Submitted
November 11, 2017
First Submitted That Met QC Criteria
November 11, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
December 30, 2020
Last Update Submitted That Met QC Criteria
December 28, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOUCSSTURAB004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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