NSAIDs Stent Study
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | July 31, 2018 |
| End Date: | October 2021 |
| Contact: | Alana Desai, MD |
| Email: | desaia@email.wustl.edu |
| Phone: | (314) |
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.
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.
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.
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.
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.
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