Mirabegron And Ureteral Stent-related Pain (MAP) Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- The primary outcome of this trial is to assess ureteral stent pain related using a visual analog scale (VAS) and the cumulative score of the 8 pain questions from the Ureteral Stent Symptom Questionnaire (USSQ).
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.
Up to 75% of patients experience pain following stenting, as well as lower urinary tract symptoms (LUTS) such as finding blood in the urine, voiding often, the need to urinate quickly resulting in a significant source of morbidity. The negative impact of stents results in a significant impact on health related quality of life.
There is no standard of care for managing ureteric stent pain and lower urinary tract symptoms following surgery. A combination of α-blockers, antimuscarinics, acetaminophen, nonsteroidal anti-inflammatory drugs and opioids are currently the mainstay for treatment of post-operative pain and LUTS following stenting.
Mirabegron is a beta-agonist that mediate relaxation of the detrusor muscle and has been useful in treating overactive bladder (OAB) which has similar symptoms to patients with an ureteric stent in place. Our goal is to assess if mirabegron can improve symptoms and decrease the need for additional pain 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
- Quadruple (Participant, Care Provider, Investigator, 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 old
- •First ureteroscopic treatment for the ureteric or renal stone
- •Retrograde semi-rigid or flexible ureteroscopy
- •Placement of a 6Fr, 22-28cm hydrophilic coated ureteric stent
- •Follow-up 7 days post operatively at St. Michael's Hospital
- •Patient who can read and understand English
排除标准
- •Bilateral ureteral stents
- •Stent in situ prior to ureteroscopy
- •Pregnancy or breast feeding, or planning on becoming pregnant in the upcoming weeks
- •Patients with congenital renal abnormalities (eg: pelvic kidney, ureteric duplication) that may impair proper stent placement
- •Patients with urinary diversion or stone in a transplant kidney
- •Patients with a history of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (eg: endometriosis), or neurogenic bladder
- •Indwelling Foley catheter
- •Patients currently taking antimuscarinics, mirabegron, or α-blockers
- •Patients with contraindications to receiving mirabegron (ie: urinary retention, end-stage renal disease, uncontrolled hypertension, known QT prolongation)
- •Significant cognitive impairment
- •Patients with contraindications to opioid use (hypersensitivity, MAO inhibitor use within 14 days, severe respiratory depression, acute or severe asthma, GI obstruction, paralytic ileus, GI stricture)
- •Suspected or confirmed ureteral perforation
- •Stent placement without tether
- •Untreated urinary tract infection
- •Antegrade ureteroscopy
- •Opioid addiction
- •Plan for stent removal at another centre other than St. Michael's Hospital
- •Moderate to severe cardiovascular disease and cerebrovascular disease
- •Signs of hepatic dysfunction including significant liver function test elevation
- •Patients who cannot read and understand English
研究组 & 干预措施
Mirabegron and narcotic analgesia
Drug: Mirabegron 50mg tablet, oral, daily from stent insertion until removal - 7days Drug: Hydromorphone 1mg tablet oral, every 4 hours as necessary Drug: Tylenol ES 500mg tablet , oral, every 6 hours as necessary
干预措施: Mirabegron 50 MG (Drug)
Placebo
Drug: Placebo for Mirabegron, 1 tablet, oral, daily from stent insertion until removal - 7days Drug:Hydromorphone 1mg tablet oral, every 4 hours as necessary Drug: Tylenol ES 500mg tablet , oral, every 6 hours as necessary
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
The primary outcome of this trial is to assess ureteral stent pain related using a visual analog scale (VAS) and the cumulative score of the 8 pain questions from the Ureteral Stent Symptom Questionnaire (USSQ).
时间窗: 7 days
The primary objective of the study is to determine if Mirabegron is effective in decreasing ureteral stent related pain following ureteroscopy when compared to placebo. The visual analog scale (VAS) is a validated, subjective method for measuring pain. The patient makes daily a handwritten mark on a 10-cm line that represents a continuum between 0 ("no pain") and 10 ("worst pain") based on his/her perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point marked by the patient. Pain will also be measured utilizing the "Body Pain" section (questions P1-P9) from the Ureteral Stent Symptoms Questionnaire (USSQ). This is a self-administered questionnaire for patients to report their symptoms for comparison, enabling the comparison between the two treatment arms. Higher scores are associated with greater intensity of symptoms reported.
次要结局
- General health score (questions G1-G6 from the Ureteral Stent Symptom Questionnaire - USSQ)(7 days)
- Work performance score (questions W1-W7 from the Ureteral Stent Symptom Questionnaire - USSQ)(7 days)
- Opioid consumption(7 days)
- Quality of life impact of Mirabegron for stent symptoms as measured with the Ureteral Stent Symptoms Questionnaire - USSQ.(7 days)