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Effect of Ureteral Stents Length and Location on Related Symptom

Primary Purpose

Lower Urinary Tract Symptoms, Overactive Bladder Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ureteral Stent of 5-16 or 5-18
Ureteral Stent of 5-22 or 5-24
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lower Urinary Tract Symptoms focused on measuring Ureteral stent, OAB

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Shuang Ho Hospital Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The intraureteral placement of distal end of ureteral stent

The conventional placement of the distal end of ureteral stent

Arm Description

Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end

Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 25, 2021
Last Updated
October 9, 2021
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05069376
Brief Title
Effect of Ureteral Stents Length and Location on Related Symptom
Official Title
Effect of Ureteral Stents Length and Location on Related Symptom
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
May 25, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Overactive Bladder Syndrome
Keywords
Ureteral stent, OAB

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Masking
Participant
Masking Description
Patients were not informed the allocation until the stent was removed.
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intraureteral placement of distal end of ureteral stent
Arm Type
Experimental
Arm Description
Patients randomized to this group received 5-16/5-18 D-J stent with intraureteral placement of the distal end
Arm Title
The conventional placement of the distal end of ureteral stent
Arm Type
Active Comparator
Arm Description
Patients randomized to this group received 5-22/5-24 D-J stent with bladder placement of the distal end
Intervention Type
Device
Intervention Name(s)
Ureteral Stent of 5-16 or 5-18
Intervention Description
Boston Scientific Polaris™ Ultra Ureteral Stent
Intervention Type
Device
Intervention Name(s)
Ureteral Stent of 5-22 or 5-24
Intervention Description
Boston Scientific Polaris™ Ultra Ureteral Stent
Primary Outcome Measure Information:
Title
Lower urinary tract symptom after placement of D-J stent
Description
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
Time Frame
Before removal of D-J stent
Secondary Outcome Measure Information:
Title
Pain after placement of D-J stent
Description
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.
Time Frame
Before removal of D-J stent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Hsun Ho, MD, PhD
Organizational Affiliation
Shuang Ho Hospital Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang Ho Hospital Taipei Medical University
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Ureteral Stents Length and Location on Related Symptom

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