Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL

March 19, 2022 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Comparison and Evaluation of USSQ (Ureteral Stent Symptom Questionnaire）, OABSS (Overactive Bladder Symptom Score), and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J（Double-J) Stents in Patients Who Underwent URL (Ureteroscopic Holmium Laser Lithotripsy）

Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire）scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Lin Zhang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
  2. Age between 18 and 80 years old and capable of providing written informed consent;
  3. In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.

Exclusion Criteria:

  1. Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
  2. Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
  3. The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation（so that we are unable to retrieve the D-J stent and conduct the in vitro experiment）.
  4. The patient refuses to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Cook D-J stent group

Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent.

Note: USI is an unexpandable acronym.
Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.
OTHER: KYB anti-reflux D-J stent group
Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.
Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.
OTHER: Urovision trigonal D-J stent group

Patients randomized to this group received Urovision (Bad Aibling, Germany, ST-230726) trigonal D-J stent.

Note: ST is an unexpandable acronym. Aibling is a German region name.
Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 1 week (after URL)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
1 week (after URL)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 1 week (after URL)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
1 week (after URL)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 4 weeks (before removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
4 weeks (before removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 4 weeks (before removal of D-J stent)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
4 weeks (before removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 5 weeks (1 week after removal of D-J stent)
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
5 weeks (1 week after removal of D-J stent)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Time Frame: 5 weeks (1 week after removal of D-J stent)
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
5 weeks (1 week after removal of D-J stent)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drainage effect of D-J stents after being removed
Time Frame: 4 weeks
The drainage effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
4 weeks
Anti-reflux effect of D-J stents after being removed
Time Frame: 4 weeks
The anti-reflux effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XHEC-C-2021-106-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

There might be other serial studies after this study, so we haven't decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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