NephrolithiasisPhase 4SPAMNCT02095665
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
A Phase 4 study testing Mirabegron, Tamsulosin and Tylenol #3 in people with Nephrolithiasis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Mirabegron, Tamsulosin and Tylenol #3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2014to 23 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years
- First presentation for ureteroscopy for this particular stone
- Planned insertion of double J ureteral stent
- Planned ureteral stenting ≥5 days
- Follow-up conducted at the Queen Elizabeth II Health Sciences Centre
Who cannot join
- Bilateral ureteral stents to be inserted
- Stent already in situ prior to ureteroscopy
- Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
- Patients with urinary diversion
- Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder
- Indwelling foley catheter
Show all 11Show fewer
- Active urinary tract infection
- Patients currently taking antimuscarinics, mirabegron, or α-blockers
- Patients with contraindications to receiving either mirabegron or tamsulosin (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
- Planned upcoming elective cataract surgery
- Suspected or confirmed ureteral perforation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Nova Scotia Health Authority, Central
Halifax, Nova Scotia, B3H 2Y9
About this study
Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.
Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. .
The investigators hypothesize that mirabegron is effective in decreasing ureteral stent related LUTS and pain.
- Conditions
- Nephrolithiasis
- Being tested
- Mirabegron, Tamsulosin, Tylenol #3
- Keywords
- ureteric stents, LUTS, lower urinary tract symptoms
- Medical subject headings
- Nephrolithiasis, 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 Myrbertiq
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
TamsulosinDrug
Also called Flomax
0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days
Tylenol #3Drug
Also called Atasol
1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
| Study group | Role | What they receive |
|---|---|---|
| Narcotic analegesic only | Active comparator | Drug:
Tylenol #3 1 tablet every six hours as necessary Receives: Drug: Tylenol #3 |
| Mirabegron and narcotic analgesia | Active comparator | Drug :
Mirabegron 50 mg oral daily
Drug:
Tylenol #3 1 tablet every six hours as necessary Receives: Drug: Mirabegron; Drug: Tylenol #3 |
| Tamsulosin and narcotic analgesia | Active comparator | Drug:
Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary Receives: Drug: Tamsulosin; Drug: Tylenol #3 |
| Mirabegron, Tamsulosin and narcotic | Experimental | Drug:
Mirabegron 50 mg oral daily
Drug:
Tamsulosin 0.4mg oral daily
Drug:
Tylenol #3 1 tablet every six hours as necessary Receives: Drug: Mirabegron; Drug: Tamsulosin; Drug: Tylenol #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
The primary objective of this study is to determine if mirabegron is effective in decreasing ureteral stent related lower urinary tract symptoms (LUTS) following ureteroscopy for urolithiasis when compared to tamsulosin alone and in combination. Utilizing the Ureteral Stent Symptom Questionnaire, a self-administered questionnaire participants will report their urinary symptoms for comparison, enabling the comparison through out the different treatment arms.
Measured: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.
Secondary outcomes (1)
Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.
The secondary objectives are to determine if mirabegron is effective in decreasing ureteral stent related pain compared to tamsulosin alone and in combination following ureteroscopy for urolithiasis, determining if there are any improvements in health related quality of life (HRQoL). Subjects will maintain a diary recording the frequency of pain medication through out the period the stent remains insitu, 5 to 10 days.
Measured: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occuring 5 to 10 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start1 Jan 2014
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea G Lantz, MD, Principal investigator, Staff Urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095665
- Sponsor's protocol ID
- SPAM
- Acronym
- SPAM
- Status last verified
- Nov 2022
- First submitted
- 17 Feb 2014
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
- ClinicalTrials.gov ID
- NCT02095665
- Acronym / sponsor ID
- SPAM / SPAM
- Conditions
- Nephrolithiasis
- Keywords
- ureteric stents, LUTS, lower urinary tract symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and or stone fragments. They are often associated with pain, voiding often, the need to urinate quickly and finding blood in the urine called "lower urinary tract symptoms" or LUTS for short. There is randomized studies showing the efficacy of α-blockers such as tamsulosin in relieving "stent symptoms" (pain and LUTS). There is emerging but limited evidence to show that antimuscarinic medications, used to treat overactive bladder (OAB) have some efficacy in decreasing stent symptoms. Mirabegron is a beta-agonist used to decrease OAB symptoms.
Mirabegron functions to mediate relaxation of the detrusor muscle and has been useful in treating OAB symptoms. Conventional antimuscarinic medications often have bothersome side effects like dry mouth, constipation, blurred vision and cognitive impairment. This may limit their use in some populations. Mirabegron is well-tolerated with a good safety profile and therefore may be useful in treating stent symptoms without the bothersome side effects commonly seen with antimuscarinic medications. .
The investigators hypothesize that mirabegron is effective in decreasing ureteral stent related LUTS and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Narcotic analegesic only | Active comparator | Drug: Tylenol #3Drug: Tylenol #3 1 tablet every six hours as necessary |
| Mirabegron and narcotic analgesia | Active comparator | Drug: Mirabegron, Drug: Tylenol #3Drug : Mirabegron 50 mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary |
| Tamsulosin and narcotic analgesia | Active comparator | Drug: Tamsulosin, Drug: Tylenol #3Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary |
| Mirabegron, Tamsulosin and narcotic | Experimental | Drug: Mirabegron, Drug: Tamsulosin, Drug: Tylenol #3Drug: Mirabegron 50 mg oral daily Drug: Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- First presentation for ureteroscopy for this particular stone
- Planned insertion of double J ureteral stent
- Planned ureteral stenting ≥5 days
- Follow-up conducted at the Queen Elizabeth II Health Sciences Centre
Key exclusion criteria (11 listed)
- Bilateral ureteral stents to be inserted
- Stent already in situ prior to ureteroscopy
- Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
- Patients with urinary diversion
- Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or 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: Myrbertiq50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days | Drug | Mirabegron and narcotic analgesia, Mirabegron, Tamsulosin and narcotic |
| TamsulosinAlso: Flomax0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days | Drug | Mirabegron, Tamsulosin and narcotic, Tamsulosin and narcotic analgesia |
| Tylenol #3Also: Atasol1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days | Drug | Mirabegron and narcotic analgesia, Mirabegron, Tamsulosin and narcotic, Narcotic analegesic only, Tamsulosin and narcotic analgesia |
Primary outcome
Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
Time frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.
The primary objective of this study is to determine if mirabegron is effective in decreasing ureteral stent related lower urinary tract symptoms (LUTS) following ureteroscopy for urolithiasis when compared to tamsulosin alone and in combination. Utilizing the Ureteral Stent Symptom Questionnaire, a self-administered questionnaire participants will report their urinary symptoms for comparison, enabling the comparison through out the different treatment arms.
1 secondary outcome
Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.
Time frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed occuring 5 to 10 days later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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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.
Andrea G Lantz, MD principal investigator
Staff Urologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron, Tamsulosin and Tylenol #3 in people with Nephrolithiasis, run by Nova Scotia Health Authority at 1 site in Canada.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 8 Nov 2022. 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 Canada. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire. (time frame: Measured twice, once at the time of surgery when stent is inserted and secondly at the time the stent is removed which will occur 5 to 10 days following surgery.). 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 8 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.