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

Urolithiasis Clinical Trial

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858750
• Other study ID #: XHEC-C-2021-106-1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2022
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive
• Urolithiasis

Intervention

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.

Locations

Country	Name	City	State
China	Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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