Stent Related Symptoms Defined by Ureteral Stent Symptom... | NCT07580963

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Variable length ureteral stent	Active Comparator		Device: Variable length ureteral stent
Image-informed length ureteral stent	Experimental		Device: Image-informed length ureteral stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Variable length ureteral stent	Device	Placement of variable length ureteral stent at the end of ureteroscopy. The variable length stent is a one-size-fits-all stent that measures 22-30cm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in scores as measured by the USSQ between the two treatment arms.	The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.	5 hours post-surgery
Differences in scores as measured by the USSQ between the two treatment arms.	The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.	Post-intervention on Day 3
Differences in scores as measured by the USSQ between the two treatment arms.	The Ureteral Stent Symptom Questionnaire (USSQ) is a validated 38-item questionnaire used to evaluate the impact of ureteral stents on a participant's quality of life. Scores will be reported for the following domains: urinary symptoms, pain, general health, work performance, and sexual matters. The range of scores for each domain are, respectively, 6-57, 6-37, 6-30, 3-15, and 0-10. In each domain, a higher score represents worse quality of life and lower score represents better quality of life.	Post-intervention on Day 7

Secondary Outcomes

Measure	Description	Time Frame
Difference in the rate of adverse events between the two treatment arms.	Adverse events include but are not limited to early stent removal due to stent-related symptoms, stent migration, and failure of stent insertion.	From enrollment until 30 days after end of treatment, an average of 5 weeks.

Eligibility Module