Effect of Ureteral Stents Length and Location on Related Symptom

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Effect of Ureteral Stents Length and Location on Related Symptom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069376
• Other study ID #: N201802031
• Status: Completed
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2021
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 30, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Device:
• Ureteral Stent of 5-16 or 5-18
Boston Scientific Polaris™ Ultra Ureteral Stent
• Ureteral Stent of 5-22 or 5-24
Boston Scientific Polaris™ Ultra Ureteral Stent

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital Taipei Medical University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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