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

Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hydronephrosis; Radiation Exposure; Ureteral Stricture
• Intervention / Treatment: Device: Coated metal ureteral stent(CMUS); Device: Double-J stent(DJS)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingrui Wang; Phone Number: 19801286883; Email: wangmingrui1995@pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peiking University People's Hospital
      • Contact: Mingrui Wang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMUS group; Coated metal ureteral stent is indwelled.	Device: Coated 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.
Other: DJS group; Double-J stent is indwelled	Device: Double-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency rate	Number of patients evaluated with hydronephrosis	Up to 36 months
Indwelling time	Number of months of the implant in the ureter	Up to 36 months
Device related serious adverse events	Number of device related serious adverse events	Up to 36 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: safety; efficacy; radiation induced ureteral stricture; coated metal ureteral stent
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Hydronephrosis
• Other Study ID Numbers: URO-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No