NCT05430646

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

Evaluation of Curative Effect of Covered Metal Ureteral Stents in the Endoscopic Treatment of Benign Short Ureteral Stricture: a Prospective Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ureteral Stenosis

Interventions

Type	Name	Description
DEVICE	Covered metal ureteral stents	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.
DEVICE	Tandem DJ stents	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-06-24
• Last updated: 2022-06-24