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

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: Recruiting
• Conditions: Urolithiasis; Overactive Bladder Syndrome
• Intervention / Treatment: Device: Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
      • Contact: Jie NA Ding, M.D.; Phone Number: 86-13564315425; Email: dingjie@xinhuamed.com.cn
      • Principal Investigator: Lin Zhang, M.D.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	1 week (after URL)
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.	1 week (after URL)
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)	4 weeks (before removal of D-J stent)
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.	4 weeks (before removal of D-J stent)
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)	5 weeks (1 week after removal of D-J stent)
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.	5 weeks (1 week after removal of D-J stent)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
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	4 weeks

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): April 30, 2023
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (ACTUAL): April 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: OABSS; USSQ; double-J stent; ureteroscopic holmium laser lithotripsy
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Urolithiasis
• Other Study ID 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