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

NCT ID: NCT04858750

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-05-31

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.

Conditions

Urolithiasis; Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

Intervention Type: DEVICE

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.

KYB anti-reflux D-J stent group

Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.

Group Type: OTHER

Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

Intervention Type: DEVICE

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.

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.

Group Type: OTHER

Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jie NA Ding, M.D.

Role: primary

dingjie@xinhuamed.com.cn

86-13564315425

Other Identifiers

XHEC-C-2021-106-1

Identifier Type: -

Identifier Source: org_study_id