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Effect of Ureteral Stents Length and Location on Related Symptom

NCT ID: NCT05069376

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2020-05-30

Brief Summary

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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

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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.

Conditions

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Lower Urinary Tract Symptoms Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: Intra-ureteral placement of double-J stent Arm 2: Conventional placement of double-J stent
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Patients were not informed the allocation until the stent was removed.

Study Groups

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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

Group Type EXPERIMENTAL

Ureteral Stent of 5-16 or 5-18

Intervention Type DEVICE

Boston Scientific Polaris™ Ultra Ureteral Stent

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

Group Type ACTIVE_COMPARATOR

Ureteral Stent of 5-22 or 5-24

Intervention Type DEVICE

Boston Scientific Polaris™ Ultra Ureteral Stent

Interventions

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Ureteral Stent of 5-16 or 5-18

Boston Scientific Polaris™ Ultra Ureteral Stent

Intervention Type DEVICE

Ureteral Stent of 5-22 or 5-24

Boston Scientific Polaris™ Ultra Ureteral Stent

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen-Hsun Ho

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chen-Hsun Ho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shuang Ho Hospital Taipei Medical University

Locations

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Shuang Ho Hospital Taipei Medical University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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N201802031

Identifier Type: -

Identifier Source: org_study_id