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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05430646
Enrollment
100
Registered
2022-06-24
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureteral Stenosis

Keywords

ureteral stricture, ureteral stent, curative effect

Brief 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.

Interventions

DEVICECovered 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.

DEVICETandem 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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Serum Creatinine (SCr)Postoperative 3-monthIt represents for the renal function change after ureteral stent insertion.
Serum Creatinine (SCr) after stent removalThree-month after stent removalIt represents for the curative effect of balloon dilatation and ureteral stent.
Postoperative Renal pelvic width (RPW)Postoperative 3-monthIt represents for the change of hydronephrosis after ureteral stent insertion.
Renal pelvic width (RPW) after stent removalThree-month after stent removalIt represents for the curative effect of balloon dilatation and ureteral stent.
Ureteral stent symptom questionnaire (USSQ)Postoperative 3-monthUSSQ represents for the quality of life of patients with ureteral stents.

Secondary

MeasureTime frameDescription
ComplicationsPostoperative 3-monthUreteral stent related complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026