Is Less More? Does Decreasing OnabotulinumtoxinA Injection Sites in the Bladder Increase Patient Satisfaction While Maintaining Efficacy?
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Incontinence Episodes Per Day
研究概览
简要总结
Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.
详细描述
Overactive bladder (OAB) is a common condition which often has a negative impact on health related quality of life. Primary and secondary treatments include behavior modification, pelvic floor physical therapy, and OAB medications. OnabotulinumtoxinA (BTX) is a well-established third line therapy for refractory OAB.
BTX has transitioned over the years from a procedure conducted in the operating room to one that is commonly done in the clinic or physician office. While ten injection sites is commonly practiced, there has been continuing interest in reducing the number of injection sites to make the technique more tolerable and more efficient.
In this study, refractory OAB patients will be randomized to receive 100 units of BTX over 3 or 10 injection sites. The investigators hypothesize that decreasing the number of injection sites may improve patient tolerability and satisfaction with this office-based procedure and potentially reduce the rates of adverse events including hematuria and urinary tract infection.
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 (Participant)
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
- •Women and men, 18 years of age or older
- •Self-reported failed conservative care of behavioral modifications and/or oral medications for the treatment of OAB
- •Average urinary frequency of > 8 voids per day as recorded on initial 3-day voiding diary
- •Self-reported bladder symptoms > 3 months
- •Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment. May restart antimuscarinics/beta-3 agonists if indicated > 6 weeks after Botox injections.
- •Capable of giving informed consent
- •Capable and willing to follow all study-related procedures
- •Previous OnabotulinumtoxinA injection at least three months prior to study enrollment.
排除标准
- •Pregnant or planning to become pregnant during study duration
- •Diagnosis of neurogenic bladder with the exception of highly functioning stroke patients
- •If a patient has had a previous neuromodulation device placed, it will have to be turned off for 2 weeks for a washout period and remain off throughout the study
- •Previous non-responders to onabotulinumtoxinA (BTX) therapy
- •Patient cannot be receiving percutaneous nerve stimulation (PTNS) therapy. If patient is receiving PTNS, they need to stop for 1 month prior to entering the study.
- •Refusal to self-catheterize or have indwelling catheter in the event of urinary retention
- •Use of investigational drug/device therapy within past 4 weeks
- •Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
- •Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
- •Pelvic radiation treatment
- •Known hypersensitivity to OnabotulinumtoxinA.
- •Previous infection at OnabotulinumtoxinA injection site.
研究组 & 干预措施
3 Injection Sites
OnabotulinumtoxinA 100Unit injection into 3 sites throughout the bladder
干预措施: OnabotulinumtoxinA 100Unit Injection (Drug)
10 Injection Sites
OnabotulinumtoxinA 100Unit injection into 10 sites throughout the bladder
干预措施: OnabotulinumtoxinA 100Unit Injection (Drug)
结局指标
主要结局
Number of Incontinence Episodes Per Day
时间窗: 3 months after the initial injection
Participants will be asked to complete a 3-day voiding diary. On the diary participants will record the number of occurrences of voids over a 24 hour period for 3 consecutive days. Number of voids at 3 months are recorded.
次要结局
- Degree of Bladder Symptom Bother(3 months after the initial injection)
- Severity of Urine Leakage(3 months after the initial injection)
- Change in Overactive Bladder Symptoms(3 months after the initial injection)
- Overall Patient Pain Tolerability With Treatment(After the initial injection)
- Overall Voiding Symptoms at 3 Months(3 months after the initial injection)
- Safety of Bladder Injections(At study completion, 3 months after the initial injection)
研究者
Larry Sirls
Attending Urologist
William Beaumont Hospitals