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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Urolithiasis; Overactive Bladder Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04858750

XHEC-C-2021-106-1

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Cook D-J stent group

Other group

Description:

Patients randomized to this group received Cook (Limerick, Ireland, USI-626-R) D-J stent. Note: USI is an unexpandable acronym.

Treatment:

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

KYB anti-reflux D-J stent group

Other group

Description:

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

Treatment:

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

Urovision trigonal D-J stent group

Other group

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.

Treatment:

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