NSAIDs Stent Study

December 15, 2025 updated by: Washington University School of Medicine

A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms

This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ureteral stent is routinely placed following ureteroscopic procedures to aid in urinary drainage post-operatively. Up to 80% of patients, however, experience stent-related symptoms (SRS) including lower abdominal pain, burning with urination, blood in urine and voiding symptoms affecting activities of their daily living. Intra- and/or post-operative therapeutic options are limited and most are initiated following the ureteral stent placement when the inflammatory process has already begun from ureteral manipulation, further limiting their efficacy. We, therefore, hypothesize that pre-operative intravenous administration of Ketorolac, with its anti-inflammatory and analgesic properties, will reduce the inflammatory process during ureteral manipulation and reduce SRS.

The eligible patients undergoing ureteral stent placement will be randomized 1:1 into either intervention or control group. Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml, whereas subjects in the control group will receive 1 ml of 0.9% injectable normal saline, prior to the start of the procedure. A panel of plasma inflammatory markers will be drawn and assessed pre- and post-operatively as well as at the time of stent removal as an objective measures for inflammation.

A follow-up telephone call will be made by the nursing staff on post-operative day one to check on patient status and to re-educate the patients to follow the protocol.

To assess SRS, all participants will complete the AUA Symptom Score Questionnaire and the Analog Pain Scale prior to the procedure. On post-operative day 1 and at the time of stent removal (prior to the stent being taken out), participants will complete the USSQ1 and the AUA Symptom Score. At the time of subsequent follow up visit, participants will complete the USSQ2 and AUA Symptom Score.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
        • Contact:
          • Aleksandra Klim, RN, BSN
          • Phone Number: (314) 747-9781
          • Email: klima@wustl.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 18 years of age and willing and able to provide informed consent
  • Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation

Exclusion Criteria:

  • Patients requiring a bilateral stone procedure.
  • Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81 mg is allowed.
  • Patients on any steroid therapy.
  • Patients with prescription anti-inflammatory drugs.
  • Patients with gastrointestinal ulcers.
  • Patients with ureteral obstruction or stricture unrelated to stone disease.
  • Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing).
  • Patients with preexisting indwelling ureteral stent
  • Patients who are pregnant or lactating.
  • Patients with renal or liver impairment.
  • Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group - Ketorlac (NSAID)
Subjects will receive a one-time intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.
Drug: Ketorolac Trometamol 30Mg/1mL Injection
Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure.
Other Names:
  • Toradol IV/IM
Placebo Comparator: Placebo Group - Normal Saline
Subjects in the control group will receive a one-time 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.
Drug: Normal saline
Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1
Time Frame: Stent insertion Day 1
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered after standard surgical procedure of ureteroscopy with or without laser lithotripsy and/or stone extraction). The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Stent insertion Day 1
Analog Pain Scale, 0 - 10 rating of pain - Stent removal
Time Frame: Stent removal visit (Approximately 7 to 14 days)
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during the stent removal visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Stent removal visit (Approximately 7 to 14 days)
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
Time Frame: 1 to 2 months post stent removal
The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during follow up visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
1 to 2 months post stent removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Alana Desai, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2018

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201804199

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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