Clinical Trial: Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Double Blind Placebo Control Trial of Mirabegron for Medical Expulsive Therapy and to Manage Stent Pain for Ureteral Stones(Protocol # 01-16-20-02)

Brief Summary: The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography) scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.

Detailed Summary: The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT scan-proven ureteral stone between 4 to 10 mm undergoing expectant management. Subjects will be distributed at a 1:1 ratio between the control and treatment groups. The treatment group will receive mirabegron and the control groups will receive a placebo. Both groups will receive analgesics and hydration will be recommended. All subjects will then be followed for 30 days to determine the proportion of subjects with spontaneous passage. Patients will record narcotic usage and pain scores during this time. If there is stone persistence in the ureter based on imaging (CT scan of the abdomen and pelvis versus renal ultrasound plus KUB), then the patient will undergo ureteroscopy with stent placement. In these patients, treatment will continue while the stent is in place and patients will fill out a validated questionnaire regarding stent pain.
Sponsor: Baylor College of Medicine

Current Primary Outcome: Spontaneous stone passage using Fisher's exact test [ Time Frame: 30 days ]

The primary analysis will compare the proportion of subjects with spontaneous stone passage within 30 days between study groups using Fisher's exact test.


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison of pain levels between treatment groups using the Wong Baker FACES pain scale [ Time Frame: 2 months ]

Pain measures between treatment groups will be measured daily for each patient by using the Wong Baker FACES pain scale. The Ureteric Stent Symptoms Questionnaire (USSQ) will be observed in patients who require surgical intervention, and will be observed during study visit 4. A general linear model will be used to compare USSQ (Ureteric Stent Symptoms Questionnaire) pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group.


Original Secondary Outcome: Comparison of pain levels between treatment groups using the Wong Baker FACES pain scale [ Time Frame: 2 months ]

Pain measures between treatment groups will be measured daily for each patient by using the Wong Baker FACES pain scale. The USSQ (Ureteric Stent Symptoms Questionnaire) will be observed in patients who require surgical intervention, and will be observed during study visit 4. A general linear model will be used to compare USSQ pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group.


Information By: Baylor College of Medicine

Dates:
Date Received: April 12, 2016
Date Started: November 2016
Date Completion: July 2018
Last Updated: October 5, 2016
Last Verified: October 2016