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NCT Number: NCT05069376

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shuang Ho Hospital Taipei Medical University

New Taipei City, 23561, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ureteral Stent of 5-16 or 5-18

Device

Boston Scientific Polaris™ Ultra Ureteral Stent

Ureteral Stent of 5-22 or 5-24

Device

Boston Scientific Polaris™ Ultra Ureteral Stent

Primary outcomes

  1. Lower urinary tract symptom after placement of D-J stent

    Time frame: 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 outcomes

  1. Pain after placement of D-J stent

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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