NCT03130907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2020

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

April 24, 2017

Last Update Submit

June 1, 2020

Conditions

Ureteroscopy

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    ED returns, Unplanned OR returns, admissions, UTIs

    30 days

Secondary Outcomes (1)

  • Subjective patient symptom scores

    6 weeks

Study Arms (2)

Stent

ACTIVE COMPARATOR
Device: Placement of ureteral stent

No stent

EXPERIMENTAL
Device: Placement of ureteral stent

Interventions

Placement of ureteral stentDEVICE

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

No stentStent

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAMC

San Antonio, Texas, 78234, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2017

First Posted

April 27, 2017

Study Start

June 1, 2017

Primary Completion

April 1, 2020

Study Completion

May 16, 2020

Last Updated

June 2, 2020

Record last verified: 2020-06

Locations

US(1)