Urinary Bladder, OveractivePhase 2NCT02462837
Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
A Phase 2 study testing Mirabegron in people with Urinary Bladder, Overactive and Pain, run by Southern Illinois University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive, Pain, Lower Urinary Tract Symptoms
- What is being tested?
- Mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 30 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18.
- Subject scheduled to undergo a ureteral stent placement for ureteral obstruction or post- ureteroscopy procedure.
- Otherwise healthy subjects who are able and willing to participate in the study.
- None of the planned interventions are documented in the labeled contraindications, warnings and precautions of the study drug.
Who cannot join
- Does NOT give consent.
- 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:
- Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months, with persistent urinary symptoms and AUASS more than 7.
- 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.
- Taken tricyclic antidepressants within 2 weeks of the first screening visit.
- 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.
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- Post void residual volume > 350 mL.
- 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.
- Subject has known neurogenic bladder.
- Subject with uncontrolled chronic pain problems or on chronic pain medications.
- 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).
- Subject has an indwelling catheter or practices intermittent self-catheterization.
- Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease, diabetic neuropathy or any neurological diseases known to affect bladder function.
- 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).
- Subject who is currently under active treatment with botulinum toxin (and all other bladder paralytics) intravesically.
- 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].
- Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine greater than 2.0 mg/dl).
- Subject has severe uncontrolled hypertension (defined as systolic blood pressure ≥180mmHg and /or diastolic pressure ≥ 110mmHg).
- 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.
- Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive ingredients.
- 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.
- 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.
- Unable to follow protocol directions due to organic brain or psychiatric disease.
- Intra-operative complications that require hospital admissions.
- History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
SIUSOM - Division of Urology
Springfield, Illinois, 62794-9665
About this study
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.
- Being tested
- Mirabegron, Placebo
- Keywords
- Ureteral Stents, Pain and Discomfort, Bladder Storage Symptoms
- Medical subject headings
- Urinary Bladder, Overactive, Pain, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Myrbetriq
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | after stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks Receives: Drug: Mirabegron |
| Placebo Arm | Placebo comparator | after stent placement, patient will be given placebo PO, once daily, for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16).
Measured: 2 weeks
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 2 weeks cannot be analyzed from baseline
Measured: 2 weeks
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 2 weeks cannot be analyzed from baseline.
Measured: 2 weeks
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study.
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16).
.
Measured: 1 week
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 1 week cannot be analyzed from baseline
Measured: 1 week
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 1 week cannot be analyzed from baseline.
Measured: 1 week
Secondary outcomes (4)
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.
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Visual analog scale is from 1-10 (10 being the worse possible pain).
Measured: 1 week, 2 weeks
Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
Only seven patients were enrolled and two of them withdrew after the fist dose. Therefore, we are only left with 5 patients completing the study. PGI-S is a four item questionnaire asking for patient enumeration of their urinary symptoms when compared to symptoms prior to surgery (1= normal, 2=mild, 3=moderate, 4=severe)
Measured: 2 weeks
Reduction in Pain Medicine Intake at the 2 Week Follow-up
This outcome measure will be listed in 1) mean number of days that pain medications were taken
Measured: 2 weeks
Reduction in Pain Medicine Intake at the 2 Week Follow-up
This outcome measure will be listed in mean number of times per day that pain medication was taken
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: insufficient rate of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc., Sisters of the Third Order of St. Francis
- Responsible party
- Sponsor
- Investigators
- Ahmed El-Zawahry, MD, Principal investigator, SIUSOM - Division of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462837
- Sponsor's protocol ID
- MYRB-14B02
- Status last verified
- May 2023
- First submitted
- 22 May 2015
- Last updated
- 13 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myrbetriq™ (Mirabegron) to Reduce Pain and Discomfort Following Ureteral Stent Placement
- ClinicalTrials.gov ID
- NCT02462837
- Acronym / sponsor ID
- MYRB-14B02
- Keywords
- Ureteral Stents, Pain and Discomfort, Bladder Storage Symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient rate of accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc., Sisters of the Third Order of St. Francis
- Study start
- May 2015
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Posted 13 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Mirabegronafter stent placement, patient will be given Mirabegron 50 mg, PO, once daily, for 2 weeks |
| Placebo Arm | Placebo comparator | Drug: Placeboafter stent placement, patient will be given placebo PO, once daily, for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18.
- Subject scheduled to undergo a ureteral stent placement for ureteral obstruction or post- ureteroscopy procedure.
- Otherwise healthy subjects who are able and willing to participate in the study.
- None of the planned interventions are documented in the labeled contraindications, warnings and precautions of the study drug.
Key exclusion criteria (25 listed)
- Does NOT give consent.
- 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:
- Post void residual volume > 350 mL.
- 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.
- Subject has known neurogenic bladder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: Myrbetriq | Drug | Treatment Arm |
| Placebo | Drug | Placebo Arm |
Primary outcome
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Time frame: 2 weeks
Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16).
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Time frame: 2 weeks
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 2 weeks cannot be analyzed from baseline
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 2 Week Follow-up Compared to Placebo Group.
Time frame: 2 weeks
Only seven patients were enrolled and two of them withdrew after the first dose. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 2 weeks cannot be analyzed from baseline.
Improvement From Baseline in the Incontinence Symptom Severity Index (ISSI) in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Time frame: 1 week
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients completing the study. Incontinence symptom severity index is a self-assessment instrument for voiding symptom severity. It assesses 8 symptom domains: emptying, urgency, urge incontinence, nocturia, daytime frequency, stress incontinence, leakage with physical activity, and pad use. absent/mild (0-6), moderate (7-16), severe (>16). .
Improvement From Baseline in the Number Micturitions Per 24 Hours in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Time frame: 1 week
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline micturitions. They were given a voiding diary after randomization to be conducted prior to their next follow-up visit. Therefore, improvement in the number of micturitions at 1 week cannot be analyzed from baseline
Improvement From Baseline in the Number of Incontinence Episodes in the Myrbetriq™ Group at the 1 Week Follow-up Compared to Placebo Group.
Time frame: 1 week
Only seven patients were enrolled and two of them withdrew after the first dose. Therefore, we are only left with 5 patients at the one week follow-up. Patients did not provide baseline number of incontinence episodes. They were given a voiding diary after randomization to be conducted pror to their next follow-up visit. Therefore, improvement in the number of incontinence episodes at 1 week cannot be analyzed from baseline.
4 secondary outcomes
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.
Time frame: 1 week, 2 weeks
Improvement From Baseline on the Patient Global Impression of Severity (PGI-S) at the 2 Week Follow-up.
Time frame: 2 weeks
Reduction in Pain Medicine Intake at the 2 Week Follow-up
Time frame: 2 weeks
Reduction in Pain Medicine Intake at the 2 Week Follow-up
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed El-Zawahry, MD principal investigator
SIUSOM - Division of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron in people with Urinary Bladder, Overactive and Pain, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.