Effect of Ureteral Stents Length and Location on Related Symptom

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.

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Overactive Bladder Syndrome
• Intervention / Treatment: Device: Ureteral Stent of 5-16 or 5-18; Device: Ureteral Stent of 5-22 or 5-24

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 23561
    • Shuang Ho Hospital Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intraureteral placement of distal end of ureteral stent; 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; Boston Scientific Polaris™ Ultra Ureteral Stent
Active Comparator: The conventional placement of the distal end of ureteral stent; 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; Boston Scientific Polaris™ Ultra Ureteral Stent

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Chen-Hsun Ho, MD, PhD, Shuang Ho Hospital Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2018
• Primary Completion (Actual): May 25, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: OAB; Ureteral stent
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms
• Other Study ID Numbers: N201802031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes