Effect of Ureteral Stents Length and Location on Related Symptom

Not Applicable

Completed

• Conditions: Overactive Bladder Syndrome; Lower Urinary Tract Symptoms
• Interventions: Device: Ureteral Stent of 5-16 or 5-18; Device: Ureteral Stent of 5-22 or 5-24

• Registration Number: NCT05069376
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief 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.

Study Timeline

• Study Start: 2018-06-12
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-30
• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Status Verified: 2021-10
• Study First Posted: 2021-10-06
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intraureteral placement of distal end of ureteral stent	Ureteral Stent of 5-16 or 5-18	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	Ureteral Stent of 5-22 or 5-24	Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end

Primary Outcome Measures

Name	Time	Method
Lower urinary tract symptom after placement of D-J stent	Before removal 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

Secondary Outcome Measures

Name	Time	Method
Pain after placement of D-J stent	Before removal 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.

Trial Locations

Locations (1)

Shuang Ho Hospital Taipei Medical University; 🇨🇳 New Taipei City, Taiwan