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Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Andrea Lantz, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT02095665
First received: February 17, 2014
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Nephrolithiasis
Drug: Mirabegron
Drug: Tamsulosin
Drug: Tylenol #3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 236
Study Start Date: November 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Narcotic analegesic only

Drug:

Tylenol #3 1 tablet every six hours as necessary

Drug: Tylenol #3
1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Name: Atasol
Active Comparator: Mirabegron and narcotic analgesia

Drug :

Mirabegron 50 mg oral daily

Drug:

Tylenol #3 1 tablet every six hours as necessary

Drug: Mirabegron
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Name: Myrbertiq
Drug: Tylenol #3
1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Name: Atasol
Active Comparator: Tamsulosin and narcotic analgesia

Drug:

Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary

Drug: Tamsulosin
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
Other Name: Flomax
Drug: Tylenol #3
1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Name: Atasol
Experimental: Mirabegron, Tamsulosin and narcotic

Drug:

Mirabegron 50 mg oral daily

Drug:

Tamsulosin 0.4mg oral daily

Drug:

Tylenol #3 1 tablet every six hours as necessary

Drug: Mirabegron
50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
Other Name: Myrbertiq
Drug: Tamsulosin
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
Other Name: Flomax
Drug: Tylenol #3
1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
Other Name: Atasol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02095665

Contacts
Contact: Andrea G Lantz, MD 9024253940 alantz@dal.ca
Contact: Leanne J MacDougall, RN 9024736604 leanne.macdougall@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Capital District health Authority Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Sub-Investigator: Ricard A Rendon, MD         
Sub-Investigator: Ashley Cox, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Andrea G Lantz, MD Staff Urologist
  More Information

No publications provided

Responsible Party: Andrea Lantz, Dr., Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT02095665     History of Changes
Other Study ID Numbers: SPAM
Study First Received: February 17, 2014
Last Updated: November 3, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Capital District Health Authority, Canada:
ureteric stents
LUTS
lower urinary tract symptoms

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Diseases
Urolithiasis
Urologic Diseases
Mirabegron
Tamsulosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014