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

NCT05430646 | Unknown DMC

• 1 other identifier: URO-03
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ureteral Stenosis

Keywords

ureteral stricture; ureteral stent; curative effect

Outcome Measures

Primary Outcomes (5)

• Postoperative Serum Creatinine (SCr)

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

  Postoperative 3-month

• Serum Creatinine (SCr) after stent removal

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

  Three-month after stent removal

• Postoperative Renal pelvic width (RPW)

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

  Postoperative 3-month

• Renal pelvic width (RPW) after stent removal

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

  Three-month after stent removal

• Ureteral stent symptom questionnaire (USSQ)

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

  Postoperative 3-month

Secondary Outcomes (1)

• Complications

  Postoperative 3-month

Study Arms (2)

CMUS group

EXPERIMENTAL

Balloon dilatation and CMUS insertion were performed in this group.

Device: Covered metal ureteral stents

Tandem DJ stent group

ACTIVE COMPARATOR

Balloon dilatation and Tandem DJ stent insertion were performed in this group.

Device: Tandem DJ stents

Interventions

Covered metal ureteral stents DEVICE

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.

CMUS group

Tandem DJ stents DEVICE

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.

Tandem DJ stent group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 24, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share