Covered Metal Ureteral Stents in the Treatment of Benign Short Ureteral Stricture

Peking University People's Hospital100 enrolled

Overview

BSUS patients were prospectively enrolled in this study, and non-randomly treated with "balloon dilation +CMUS" and "balloon dilation + tandem DJ stent". Perioperative data of the patients were recorded to compare their efficacy and complications, and the ureteral stent symptom questionnaire was used to compare their impact on patients' quality of life. CMUS and tandem DJ stents were removed after ≥3 months of indwelling. After the removal of stents, the patients' serum creatinine and renal pelvis width were followed up to compare their curative effect on BSUS.

The ureteral stricture is caused by various benign and malignant reasons, and then appears hydronephrosis and progressive decline of renal function. Benign short ureteral stenosis (BSUS) especially refers to ureteral stenosis of no more than 2cm in length caused by benign causes such as impacted ureteral stone or endoscopic lithotomy. Currently, BSUS can be treated with laparoscopic or open ureteroplasty, endoscopic balloon dilation or ureterotomy, ureteral stents insertion, or nephrostomy. Since its introduction, covered metal ureteral stent (CMUS) can be used to treat various types of ureteral stricture, achieving a long-term patency rate of more than 80% for BSUS and even curing some patients. It also has fewer complications than a double-J stent (DJ stent). However, there is still a lack of comparative studies on the therapeutic effect and complications of the two treatment methods, namely CMUS after balloon dilation and tandem DJ stent, for BSUS, especially the evaluation of the curative effect of BSUS. Therefore, BSUS patients were prospectively enrolled in this study, and non-randomly treated with "balloon dilation +CMUS" and "balloon dilation + tandem DJ stent". Perioperative data of the patients were recorded to compare their efficacy and complications, and the ureteral stent symptom questionnaire was used to compare their impact on patients' quality of life. CMUS and tandem DJ stents were removed after ≥3 months of indwelling. After the removal of stents, the patients' serum creatinine and renal pelvis width were followed up to compare their curative effect on BSUS.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Conditions

Ureteral Stenosis

Interventions

Covered metal ureteral stentsDEVICE

The CMUS is a fully covered, self-expanding, large caliber metal stent. The stent is made of super-elastic nickel-titanium alloy, which maintain lumen patency via providing long-term direct wall support.

Tandem DJ stentsDEVICE

Tandem DJ stents represents for two stents side-by-side, which improves the urine flow by better withstanding the compressive tumoral forces and allowing urine to flow between the stents.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BSUS patients from January 2023 to January 2024 in Peking University People's Hospital, no gender limitation, aged from 18 to 80, Benign ureteral stricture with definite reason (ureteropelvic junction obstruction, ischemic ureter stenosis caused by surgical separation, ureter partial excision anastomosis stricture after operation, ureteral stricture caused by ureteral endoscope surgery, ureteral stenosis caused by impacted ureteral calculi, ureteral anastomotic stricture after urinary flow diversion, ureteral anastomotic stricture after kidney transplantation, retroperitoneal fibrosis, ureteral stricture caused by trauma, idiopathic ureteral stricture), patients can tolerate anesthesia and surgery and obtain informed consent. Exclusion Criteria: * Patients with hypertonic neurogenic bladder, severe bladder outlet obstruction or bladder capacity less than 50ml, combined with sepsis, incomplete clinical data, failed stent implantation, insufficient indwelling time (\< 3 months), postoperative loss of follow-up.

Outcomes

Primary Outcomes

Postoperative Serum Creatinine (SCr)

It represents for the renal function change after ureteral stent insertion.

Time frame: Postoperative 3-month

Serum Creatinine (SCr) after stent removal

It represents for the curative effect of balloon dilatation and ureteral stent.

Time frame: Three-month after stent removal

Postoperative Renal pelvic width (RPW)

It represents for the change of hydronephrosis after ureteral stent insertion.

Time frame: Postoperative 3-month

Renal pelvic width (RPW) after stent removal

It represents for the curative effect of balloon dilatation and ureteral stent.

Time frame: Three-month after stent removal

Ureteral stent symptom questionnaire (USSQ)

USSQ represents for the quality of life of patients with ureteral stents.

Time frame: Postoperative 3-month

Secondary Outcomes

Complications

Ureteral stent related complications

Time frame: Postoperative 3-month

Data from ClinicalTrials.gov

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