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

Not Applicable

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

• Registration Number: NCT04858750
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-03-22
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Urovision trigonal D-J stent group	Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy	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.
Cook D-J stent group	Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy	Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent. Note: USI is an unexpandable acronym.
KYB anti-reflux D-J stent group	Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy	Patients randomized to this group received KYB (Shenzhen, China, 3201162) anti-reflux D-J stent.

Primary Outcome Measures

Name	Time	Method
Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent	5 weeks (1 week after removal of D-J stent)	The patients' symptoms are evaluated by OABSS ( Overactive Bladder Symptom Score) scale.

Secondary Outcome Measures

Name	Time	Method
Drainage effect of D-J stents after being removed	4 weeks	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	4 weeks	The anti-reflux effect of D-J stents removed from the ureters of patients are measured in vitro under liquid manometer

Trial Locations

Locations (1)

Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China