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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The intraureteral placement of distal end of ureteral stent | Experimental | Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end |
|
| The conventional placement of the distal end of ureteral stent | Active Comparator | Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ureteral Stent of 5-16 or 5-18 | Device | Boston Scientific Polaris™ Ultra Ureteral Stent |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen-Hsun Ho, MD, PhD | Shuang Ho Hospital Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuang Ho Hospital Taipei Medical University | New Taipei City | 23561 | Taiwan |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
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Patients were not informed the allocation until the stent was removed.
| Ureteral Stent of 5-22 or 5-24 | Device | Boston Scientific Polaris™ Ultra Ureteral Stent |
|