Effect of Ureteral Stents Length and Location on Related Symptom

Study Overview
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Brief Summary
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This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.

Detailed Description
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Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.

Official Title
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Effect of Ureteral Stents Length and Location on Related Symptom

Conditions
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Lower Urinary Tract Symptoms, Overactive Bladder Syndrome

Intervention / Treatment
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* Device: Ureteral Stent of 5-16 or 5-18
* Device: Ureteral Stent of 5-22 or 5-24


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of unilateral ureteral stone Plan to undergo unilateral URS lithotripsy Adult patients (>18 years old) Exclusion Criteria: Pre-stented cases Distal ureteral stones Preoperative urinary tract infection With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist Pregnancy Other procedures required during the procedure of lithotripsy A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intraureteral placement of distal end of ureteral stent<br>Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end | Device: Ureteral Stent of 5-16 or 5-18<br>* Boston Scientific Polaris™ Ultra Ureteral Stent<br>|
| Active Comparator: The conventional placement of the distal end of ureteral stent<br>Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end | Device: Ureteral Stent of 5-22 or 5-24<br>* Boston Scientific Polaris™ Ultra Ureteral Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower urinary tract symptom after placement of D-J stent | The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) urinary index. The minimum and maximum values are 11 and 53, and the higher scores mean a worse outcome | Before removal of D-J stent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after placement of D-J stent | The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) pain index and general health index. The minimum and maximum values of the body pain index are 2 and 43. The minimum and maximum values of the general health index are 4 and 28. The higher scores of both mean a worse outcome. | Before removal of D-J stent | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral stent, OAB