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

Ureteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130907
• Other study ID #: C.2017.070
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 16, 2020

Study information

• Verified date: June 2020
• Source: San Antonio Uniformed Services Health Education Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 16, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Ureteroscopy

Intervention

Device:
• Placement of ureteral stent
will randomize groups to either receive a postoperative ureteral stent or not.

Locations

Country	Name	City	State
United States	BAMC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Uniformed Services Health Education Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	ED returns, Unplanned OR returns, admissions, UTIs	30 days
Secondary	Subjective patient symptom scores	symptom questionnaires	6 weeks