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NCT Number: NCT02095665

Ureteral Stent-related Pain and Mirabegron (SPAM) Trial

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.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nova Scotia Health Authority, Central

Halifax, Nova Scotia, B3H 2Y9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirabegron

Drug

50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days

Other names: Myrbertiq

Tamsulosin

Drug

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 names: Flomax

Tylenol #3

Drug

1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days

Other names: Atasol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Acronym: SPAM

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2014
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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