Hydronephrosis, Radiation Exposure, Ureteral Stricture
Conditions
Keywords
radiation induced ureteral stricture, coated metal ureteral stent, safety, efficacy
Brief summary
A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.
Interventions
DEVICECoated metal ureteral stent(CMUS)
Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.
DEVICEDouble-J stent(DJS)
Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.
Sponsors
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of ureteral stricture and hydronephrosis. 2. Previous history of radiation therapy. 3. Must be able to tolerate surgery.
Exclusion criteria
1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter). 2. Colon resection surgery patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | Up to 36 months | Number of patients evaluated with hydronephrosis |
| Indwelling time | Up to 36 months | Number of months of the implant in the ureter |
| Device related serious adverse events | Up to 36 months | Number of device related serious adverse events |
Countries
China
Contacts
Primary ContactMingrui Wang
Outcome results
None listed