NCT05069376

Effect of Ureteral Stents Length and Location on Related Symptom

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Lower Urinary Tract Symptoms
• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DEVICE	Ureteral Stent of 5-16 or 5-18	Boston Scientific Polaris™ Ultra Ureteral Stent
DEVICE	Ureteral Stent of 5-22 or 5-24	Boston Scientific Polaris™ Ultra Ureteral Stent

Timeline

• Start date: 2018-06-12
• Primary completion: 2020-05-25
• Completion: 2020-05-30
• First posted: 2021-10-06
• Last updated: 2021-10-18

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study