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NSAIDs Stent Study

Primary Purpose

Ureteral Stent Placement, Kidney Stone

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Trometamol 30Mg/1mL Injection
Normal saline
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ureteral Stent Placement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group - Ketorlac (NSAID)

Placebo Group - Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Analog Pain Scale, 0 - 10 rating of pain - 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.
Analog Pain Scale, 0 - 10 rating of pain - Stent removal
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.
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
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.

Secondary Outcome Measures

Full Information

First Posted
July 26, 2018
Last Updated
October 9, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03638999
Brief Title
NSAIDs Stent Study
Official Title
A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Stent Placement, Kidney Stone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in 1:1 ratio to 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. Study team, with the exception of the pharmacist, will be blinded to randomization results.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Prior to initiation of study enrollment, envelopes containing study randomization assignments will be created, sequentially numbered, sealed and given to the study pharmacist. Once a patient provides consent and meets study inclusion and exclusion criteria, study pharmacist will be notified of enrollment and will randomize the patient by opening the next subsequent randomization envelope.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group - Ketorlac (NSAID)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group - Normal Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Trometamol 30Mg/1mL Injection
Other Intervention Name(s)
Toradol IV/IM
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.
Primary Outcome Measure Information:
Title
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1
Description
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.
Time Frame
Stent insertion Day 1
Title
Analog Pain Scale, 0 - 10 rating of pain - Stent removal
Description
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.
Time Frame
Stent removal visit (Approximately 7 to 14 days)
Title
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit
Description
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.
Time Frame
1 to 2 months post stent removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alana Desai, MD
Phone
(314)
Email
desaia@email.wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Bergeron, CCRP
Phone
(314) 454-7325
Email
bergeronk@email.wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alana Desai, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Bergeron
Phone
314-454-7325
Email
bergeronk@email.wustl.edu
First Name & Middle Initial & Last Name & Degree
Aleksandra Klim, RN, BSN
Phone
(314) 747-9781
Email
klima@wustl.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
27238615
Citation
Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART II. J Urol. 2016 Oct;196(4):1161-9. doi: 10.1016/j.juro.2016.05.091. Epub 2016 May 27.
Results Reference
background
PubMed Identifier
12576847
Citation
Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.
Results Reference
background
PubMed Identifier
21453351
Citation
Lamb AD, Vowler SL, Johnston R, Dunn N, Wiseman OJ. Meta-analysis showing the beneficial effect of alpha-blockers on ureteric stent discomfort. BJU Int. 2011 Dec;108(11):1894-902. doi: 10.1111/j.1464-410X.2011.10170.x. Epub 2011 Mar 31.
Results Reference
background
PubMed Identifier
18339420
Citation
Norris RD, Sur RL, Springhart WP, Marguet CG, Mathias BJ, Pietrow PK, Albala DM, Preminger GM. A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort. Urology. 2008 May;71(5):792-5. doi: 10.1016/j.urology.2007.11.004. Epub 2008 Mar 12.
Results Reference
background
PubMed Identifier
21965355
Citation
De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
Results Reference
background
PubMed Identifier
19888977
Citation
Elwood CN, Lange D, Nadeau R, Seney S, Summers K, Chew BH, Denstedt JD, Cadieux PA. Novel in vitro model for studying ureteric stent-induced cell injury. BJU Int. 2010 May;105(9):1318-23. doi: 10.1111/j.1464-410X.2009.09001.x. Epub 2009 Nov 3.
Results Reference
background
PubMed Identifier
15659891
Citation
Beiko DT, Watterson JD, Knudsen BE, Nott L, Pautler SE, Brock GB, Razvi H, Denstedt JD. Double-blind randomized controlled trial assessing the safety and efficacy of intravesical agents for ureteral stent symptoms after extracorporeal shockwave lithotripsy. J Endourol. 2004 Oct;18(8):723-30. doi: 10.1089/end.2004.18.723.
Results Reference
background
PubMed Identifier
20092835
Citation
Krambeck AE, Walsh RS, Denstedt JD, Preminger GM, Li J, Evans JC, Lingeman JE; Lexington Trial Study Group. A novel drug eluting ureteral stent: a prospective, randomized, multicenter clinical trial to evaluate the safety and effectiveness of a ketorolac loaded ureteral stent. J Urol. 2010 Mar;183(3):1037-42. doi: 10.1016/j.juro.2009.11.035. Epub 2010 Jan 21.
Results Reference
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NSAIDs Stent Study

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