Clinical trial NCT04858750: 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
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）
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Overactive Bladder Syndrome
Keywords: USSQ
OABSS
double-J stent
ureteroscopic holmium laser lithotripsy
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 1 week (after URL)
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 1 week (after URL)
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 4 weeks (before removal of D-J stent)
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 4 weeks (before removal of D-J stent)
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 5 weeks (1 week after removal of D-J stent)
measure: Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent
timeFrame: 5 weeks (1 week after removal of D-J stent)
Secondary outcomes:
measure: Drainage effect of D-J stents after being removed
timeFrame: 4 weeks
measure: Anti-reflux effect of D-J stents after being removed
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: