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

Not Applicable

Recruiting

• Conditions: Ureteral Stricture; Radiation Exposure; Hydronephrosis
• Interventions: Device: Coated metal ureteral stent(CMUS); Device: Double-J stent(DJS)

• Registration Number: NCT04441320
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2021-01-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMUS group	Coated metal ureteral stent(CMUS)	Coated metal ureteral stent is indwelled.
DJS group	Double-J stent(DJS)	Double-J stent is indwelled

Primary Outcome Measures

Name	Time	Method
Device related serious adverse events	Up to 36 months	Number of device related serious adverse events
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

Trial Locations

Locations (1)

Peiking university people's hospital; 🇨🇳 Beijing, Beijing, China