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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Multicenter Study of Balloon Dilatation for the Treatment of Benign

Conditions
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Stricture Ureter

Intervention / Treatment
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* Device: balloon dilatation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Subject has provided informed consent and indicated a willingness to comply with study 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, intravenous pyelography or retrograde pyelography; Subject's ureteral stenosis length is ≤ 2cm (single or multiple segments) Exclusion Criteria: • Subject has any congenital ureteral anatomical deformity, abdominal organ compression, 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 stone obstruction 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, lung disfuction or other diseases that could not tolerate the endoscopic surgery or anesthesia. Subject has unadjusted diabetes or high blood pressure Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| F21<br>balloon diameter F21 | Device: balloon dilatation<br>* The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the bee waist sign disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)<br>|
| F24<br>balloon diameter F24 | Device: balloon dilatation<br>* The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the bee waist sign disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment success in follow-up results after 6 months | The treatment is effective (satisfying any of the following 3 items, that is, the treatment is considered effective) Treatment failure (not satisfying any of the following 3 items is invalid, that is, treatment failure) Retrograde pyelography normal development; ECT shows improvement in renal function on the affected side; CT shows the reduced hydronephrosis. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of treatment success during the operation | Effective: the balloon is expanded through the stenosis segment, and the diameter of the ureteral tube is obviously thickened after expansion, and the scar tissue is obviously torn, and the surrounding adipose tissue is visible; Failure: The guidewire or balloon cannot pass through the stenotic segment of the ureter and cannot expand the stenosis (the scar tissue is not torn). | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign ureteral stricture, balloon dilatation