The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial

NCT ID: NCT03130907

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-05-16

Brief Summary

It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.

Conditions

Ureteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Stent

Group Type: ACTIVE_COMPARATOR

Placement of ureteral stent

Intervention Type: DEVICE

will randomize groups to either receive a postoperative ureteral stent or not.

No stent

Group Type: EXPERIMENTAL

Placement of ureteral stent

Intervention Type: DEVICE

will randomize groups to either receive a postoperative ureteral stent or not.

Interventions

Placement of ureteral stent

will randomize groups to either receive a postoperative ureteral stent or not.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.

Exclusion Criteria

• Stone size greater than 1.5 cm on preoperative imaging
• Pregnancy
• Stent placement prior to ureteroscopy ("pre-stented patients")
• Patients with solitary kidney

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Antonio Uniformed Services Health Education Consortium

FED

Sponsor Role: lead

Responsible Party

Amy Reed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BAMC

San Antonio, Texas, United States

Countries

United States

Other Identifiers

C.2017.070

Identifier Type: -

Identifier Source: org_study_id