A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture

Phase

N/A

Condition

Aneurysm

Treatment

N/A

Clinical Study ID

NCT04021901

SHOT-20181112

Ages 18-70
All Genders

Study Summary

This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• Subject has provided informed consent and indicated a willingness to comply withstudy treatments
Subject is 18-70 yrs of age
Subject can be either male or female
Subject diagnosed with ureteral stricture or atresia by enhanced CTU, intravenouspyelography or retrograde pyelography;
Subject's ureteral stenosis length is ≤ 2cm (single or multiple segments)

Exclusion

Exclusion Criteria:

• Subject has any congenital ureteral anatomical deformity, abdominal organcompression, oppression caused by malignant tumor metastasis
Subject has poor result after endoscopic balloon dilatation treatment
Subject has a GFR <25% on the affected side of the kidney
Subject has an active urinary tract infection (e.g., cystitis, prostatitis,urethritis, etc.)
Subject has been diagnosed with a urethral stricture or bladder neck contracture
Subject has been diagnosed with a urinary tract infection related to stoneobstruction within two weeks
Subject has severe hematuria that might blur the vision of the endoscopy
Subject is pregnant or in monthly period
Subject has coexistent disease like systemic disease, heart disease, lungdisfuction or other diseases that could not tolerate the endoscopic surgery oranesthesia.
Subject has unadjusted diabetes or high blood pressure
Subject has a disorder of the coagulation cascade system that would put thesubject at risk for intraoperative or postoperative bleeding
Subject is unable to discontinue anticoagulant and antiplatelet therapypreoperatively (2 weeks)

Study Design

November 01, 2018

December 31, 2019

Study Description

Benign ureteral stricture refers to a urinary tract obstruction caused by a partial or full ureteral lumen that is less normal than normal. It can lead to urinary dilatation, water accumulation, and renal colic in the upper segment of the stenosis. If treat not in time, it will affect renal function and even causes irreversible kidney failure.In recent years, with the development of endoscopic techniques, it provides a cost-effective and less invasive treatment for the treatment of ureteral stricture. In recent years, with the development of endoscopic techniques, it has provided a cost-effective and less invasive treatment for the treatment of ureteral stricture, and has achieved satisfactory results. Therefore, more and more urologists choose to treat ureteral stricture under endoscopy. The techniques of urinary endoscopic treatment of benign ureteral stricture include ureteral balloon dilatation, ureteral holmium laser incision, and ureteral stent implantation. Among them, the ureteral balloon dilatation technique is characterized by the use of a balloon to uniformly force the ureteral wall, tearing the narrow scar tissue, expanding the inner diameter of the ureter, recanalizing the urinary tract, and alleviating hydronephrosis. It have been reported with less complications and simple procedure. However, there's still no consensus on its treatment indication，procedure standards and curative effect. This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.

Connect with a study center

Changhai Hospital
Shanghai, Shanghai 200433
China
Active - Recruiting

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