Overactive Bladder Syndrome, Urolithiasis
Conditions
Keywords
USSQ, OABSS, double-J stent, ureteroscopic holmium laser lithotripsy
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.
Interventions
DEVICEPlacement 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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hematuria, lower urinary tract symptoms and other aspects after placement of D-J stent | 1 week (after URL) | The patients' symptoms are evaluated by complete USSQ (Ureteral Stent Symptom Questionnaire) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed