Ureteral Stent-related Pain and Mirabegron (SPAM) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Narcotic analegesic only
Drug:
Tylenol #3 1 tablet every six hours as necessary
干预措施: Tylenol #3 (Drug)
Mirabegron and narcotic analgesia
Drug :
Mirabegron 50 mg oral daily
Drug:
Tylenol #3 1 tablet every six hours as necessary
干预措施: Mirabegron (Drug)
Mirabegron and narcotic analgesia
Drug :
Mirabegron 50 mg oral daily
Drug:
Tylenol #3 1 tablet every six hours as necessary
干预措施: Tylenol #3 (Drug)
Tamsulosin and narcotic analgesia
Drug:
Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary
干预措施: Tamsulosin (Drug)
Tamsulosin and narcotic analgesia
Drug:
Tamsulosin 0.4mg oral daily Drug: Tylenol #3 1 tablet every six hours as necessary
干预措施: Tylenol #3 (Drug)
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
干预措施: Mirabegron (Drug)
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
干预措施: Tamsulosin (Drug)
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
干预措施: Tylenol #3 (Drug)
结局指标
主要结局
Ureteral stent related pain and lower urinary tract symptoms (LUTS) as measured by the Ureteral Stent Symptom Questionnaire.
时间窗: 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.
次要结局
- Quality of life impact of mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire.(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.)