Effect of Ureteral Stents Length and Location on Related Symptom

NCT05069376 | Completed FDA Device

• 1 other identifier: N201802031
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Overactive Bladder Syndrome

Keywords

Ureteral stent; OAB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain after placement of D-J stent

  Before removal of D-J stent

Study Arms (2)

The intraureteral placement of distal end of ureteral stent

EXPERIMENTAL

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

The conventional placement of the distal end of ureteral stent

ACTIVE COMPARATOR

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

Interventions

Ureteral Stent of 5-16 or 5-18 DEVICE

Boston Scientific Polaris™ Ultra Ureteral Stent

The intraureteral placement of distal end of ureteral stent

Ureteral Stent of 5-22 or 5-24 DEVICE

Boston Scientific Polaris™ Ultra Ureteral Stent

The conventional placement of the distal end of ureteral stent

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of unilateral ureteral stone
• Plan to undergo unilateral URS lithotripsy
• Adult patients (\>18 years old)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuang Ho Hospital Taipei Medical University

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen-Hsun Ho, MD, PhD

  Shuang Ho Hospital Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were not informed the allocation until the stent was removed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: June 12, 2018
• Primary Completion: May 25, 2020
• Study Completion: May 30, 2020
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)