Back to resultsComparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL
Primary Purpose
Urolithiasis, Overactive Bladder Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring USSQ, OABSS, double-J stent, ureteroscopic holmium laser lithotripsy
Eligibility Criteria
Inclusion Criteria:
- 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.
- Age between 18 and 80 years old and capable of providing written informed consent;
- 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:
- 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.
- Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
- 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）.
- The patient refuses to sign the informed consent.
Sites / Locations
- Xinhua Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Cook D-J stent group
KYB anti-reflux D-J stent group
Urovision trigonal D-J stent group
Arm Description
Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent. Note: USI is an unexpandable acronym.
Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.
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.
Outcomes
Primary Outcome Measures
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Secondary Outcome Measures
Drainage effect of D-J stents after being removed
The drainage effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Anti-reflux effect of D-J stents after being removed
The anti-reflux effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Full Information
NCT ID
NCT04858750
First Posted
April 14, 2021
Last Updated
March 19, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04858750
Brief Title
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
Official Title
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）
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Overactive Bladder Syndrome
Keywords
USSQ, OABSS, double-J stent, ureteroscopic holmium laser lithotripsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cook D-J stent group
Arm Type
Other
Arm Description
Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent.
Note: USI is an unexpandable acronym.
Arm Title
KYB anti-reflux D-J stent group
Arm Type
Other
Arm Description
Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.
Arm Title
Urovision trigonal D-J stent group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Time Frame
1 week (after URL)
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Time Frame
1 week (after URL)
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Time Frame
4 weeks (before removal of D-J stent)
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Time Frame
4 weeks (before removal of D-J stent)
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire)
Time Frame
5 weeks (1 week after removal of D-J stent)
Title
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
Description
The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.
Time Frame
5 weeks (1 week after removal of D-J stent)
Secondary Outcome Measure Information:
Title
Drainage effect of D-J stents after being removed
Description
The drainage effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Time Frame
4 weeks
Title
Anti-reflux effect of D-J stents after being removed
Description
The anti-reflux effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Age between 18 and 80 years old and capable of providing written informed consent;
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:
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.
Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
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）.
The patient refuses to sign the informed consent.
Facility Information:
Facility Name
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie NA Ding, M.D.
Phone
86-13564315425
Email
dingjie@xinhuamed.com.cn
First Name & Middle Initial & Last Name & Degree
Lin Zhang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There might be other serial studies after this study, so we haven't decided yet.
Learn more about this trial
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
We'll reach out to this number within 24 hrs