Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial

Conditions
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Pain, Symptoms and Signs, Ureteral Calculi

Intervention / Treatment
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* Other: Administration of USSQ Symptoms questionnaire after stent positioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suture stent<br>suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. | Other: Administration of USSQ Symptoms questionnaire after stent positioning<br>* Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy<br>|
| Active Comparator: conventional double-J stent<br>conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire. | Other: Administration of USSQ Symptoms questionnaire after stent positioning<br>* Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Symptom Index Score | 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 | to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery | 14 days | 
| USSQ domains' scores | to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery | 2 days | 
| USSQ single answers | to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery | 14 day | 
| USSQ single answers | 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 | to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group | 6 weeks | 
| complications and adverse events | to compare complications and adverse events of suture stent and double J group | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Symptoms and Signs, Ureteral Calculi, Ureteroscopy, Ureteral Stents