Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture

Peking University

Status: Enrolling

Conditions: Hydronephrosis; Ureteral Stricture; Radiation Exposure

Treatments: Device: Coated metal ureteral stent(CMUS); Device: Double-J stent(DJS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04441320

URO-02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

CMUS group

Experimental group

Description:

Coated metal ureteral stent is indwelled.

Treatment:

Device: Coated metal ureteral stent(CMUS)

DJS group

Other group

Description:

Double-J stent is indwelled

Treatment:

Device: Double-J stent(DJS)