The objective of this pilot study is to assess whether Myrbetriq™ will improve post-operative
ureteral pain and discomfort, reduce bladder storage symptoms and increase quality of life
following ureteral stenting.
1. Age ≥ 18.
2. Subject scheduled to undergo a ureteral stent placement for ureteral obstruction or
post- ureteroscopy procedure.
3. Otherwise healthy subjects who are able and willing to participate in the study.
4. None of the planned interventions are documented in the labeled contraindications,
warnings and precautions of the study drug.
1. Does NOT give consent.
2. Subject is using prohibited medications which cannot be stopped safely at the
screening visit. Subject is excluded if using restricted medications not meeting
(i) Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months, with
persistent urinary symptoms and AUASS more than 7.
(ii) Taken an oral alpha agonist, anticholinergic or cholinergic medication within 5
days of the first screening visit with the following exception(s): a singular dose
given in ER or on the hospital floor prior to procedure, topical anticholinergic eye
drops used for glaucoma or inhaled anti-cholinergic used for COPD.
(iii) Taken tricyclic antidepressants within 2 weeks of the first screening visit.
(iv) Taken an estrogen, androgen, or any drug producing androgen suppression, or
anabolic steroids within 3 months with the following exceptions: any topical creams
for local treatment.
3. Post void residual volume > 350 mL.
4. Female subject is breastfeeding, pregnant, intends to become pregnant during the
study, or of childbearing potential is sexually active and not practicing a highly
reliable method of birth control.
5. Subject has known neurogenic bladder.
6. Subject with uncontrolled chronic pain problems or on chronic pain medications.
7. Subject has significant stress incontinence or mixed stress/urgency incontinence where
stress is the predominant factor as determined by the investigator (for female
subjects confirmed by a cough provocation test).
8. Subject has an indwelling catheter or practices intermittent self-catheterization.
9. Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease,
diabetic neuropathy or any neurological diseases known to affect bladder function.
10. Subject has evidence of a symptomatic active urinary tract infection, chronic
inflammation such as interstitial cystitis, previous pelvic radiation therapy or
previous or current malignant disease of the pelvic organs, or bladder stones (which
can be located in different anatomical location and can cause LUTS similar to bladder
infection and pain related to their location in the bladder which could mask the
11. Subject who is currently under active treatment with botulinum toxin (and all other
bladder paralytics) intravesically.
12. Subject has moderate to severe hepatic impairment [ALT (SGPT) or AST (SGOT) value
greater than 3 times the upper limit of normal in the clinical center lab; confirmed
on a second measurement].
13. Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine
greater than 2.0 mg/dl).
14. Subject has severe uncontrolled hypertension (defined as systolic blood pressure
≥180mmHg and /or diastolic pressure ≥ 110mmHg).
15. Subject has a clinically significant abnormal ECG in their chart or has a known
history of QT prolongation or currently taking medication known to prolong the QT
interval. Any patient taking Digoxin.
16. Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive
17. Subject has a concurrent genitourinary malignancy, or active cancer (except
noninvasive skin cancer) within the last 5 years prior to screening. Men with a
history of prostate cancer regardless of curability are not eligible.
18. Subject has been treated with an experimental device within 30 days or received an
experimental agent within the longer of 30 days or five half-lives.
19. Unable to follow protocol directions due to organic brain or psychiatric disease.
20. Intra-operative complications that require hospital admissions.
21. History of alcoholism or any other substance abuse, which, in the opinion of the
investigator, would affect compliance with the protocol.