Clinical trial NCT02462837: Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
Official title: Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urinary Bladder, Overactive
Pain
Lower Urinary Tract Symptoms
Keywords: Ureteral Stents
Pain and Discomfort
Bladder Storage Symptoms
Lead sponsor: Southern Illinois University
Sponsor class: OTHER
Collaborators: name: Astellas Scientific & Medical Affairs, Inc.
name: Sisters of the Third Order of St. Francis
First posted: 2015-06-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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 protocol-specified criteria:

   (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 treatment effect).
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 ingredients.
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.

Primary outcomes:
measure: Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
timeFrame: 2 weeks
measure: Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
timeFrame: 2 weeks
measure: Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
timeFrame: 2 weeks
measure: Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
timeFrame: 1 week
measure: Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
timeFrame: 1 week
measure: Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
timeFrame: 1 week
Secondary outcomes:
measure: Improvement in Pain and Discomfort Perception Using a 10 Point Visual Analog Scale for Pain Assessment (VAS) at the 1 and 2 Week Follow-up.
timeFrame: 1 week, 2 weeks
measure: Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
timeFrame: 2 weeks
measure: Reduction in Pain Medicine Intake at the 2 Week Follow-up
timeFrame: 2 weeks
measure: Reduction in Pain Medicine Intake at the 2 Week Follow-up
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: SIUSOM - Division of Urology
state: Illinois
Study officials:
affiliation: SIUSOM - Division of Urology
name: Ahmed El-Zawahry, MD
role: PRINCIPAL_INVESTIGATOR
References: