Comparative Study of Safety and Efficacy Between 100 U Suburothelial Injection and 50 U Suburothelial Plus 50 U Urethral Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Net change of the Patients Perception of Bladder Condition (PPBC)
研究概览
简要总结
The objectives of this study is to evaluate and compare the efficacy and safety between 100 U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A suburothelial injections and 50 U urethral injection for the treatment of detrusor overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents
详细描述
Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence, usually no metabolic or anatomical disorders can be found and it may have great impact on quality of life. OAB symptoms were found to have a significant effect on the emotional well-being and productivity of those affected. Although there are several new therapeutic options with promising treatment outcome, antimuscarinic drugs remain the first line treatment and clinical effects with good tolerability have been confirmed. However, not all OAB patients can benefit from antimuscarinic agent, and this treatment has some adverse effects such as dizziness, dry mouth, blurred vision, and constipation, which are intolerable for some patients. Of these patients intravesical botulinum toxin (BoNT) injections provide an alternative treatment with a favorable efficacy.
Based on the understanding of the pathophysiology of OAB and detrusor overactivity (DO), BoNT has been enthusiastically applied in treating urinary urgency or incontinence refractory to antimuscarinics in recent years. Although promising therapeutic effects have been confirmed by several case series or clinical trials, the occurrence of adverse events are reported inconsistently. Analysis of patients demographics and urodynamic variables reveals that patients with ageing, low detrusor contractility, with chronic medical disease carry risks of adverse events. Although safety and efficacy were similar between elderly patients without frailty and younger patients, an increased risk of large post-void residual urine volume and a lower long-term success rate in frail elderly patients were noted after intravesical 100 U BoNT-A injection for refractory idiopathic DO. Therefore, careful dose and injection site adjustment and patient selection is mandatory to achieve satisfactory results using intravesical BoNT-A therapy.
This study aimed at compare the safety and efficacy between 100 U suburothelial injection and combined 50 U suburothelial and 50 U urethral sphincter injection of BoNT-A in patients with detrusor overactivity and inadequate contractility (DHIC). A total of 60 patients with DHIC will be enrolled and randomly allocated to each group and treated with either regimen. The safety and efficacy will be assessed by the Patient's Perception of Bladder Condition (PPBC) at different time points after injection. The results of this study may provide valuable evidence for the rational treatment regimen for patients with DHIC.
Estimated Total Sample Size 60 evaluable patients in total will be recruited
Method of Patient Assignment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was designed in this study
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with age of 20 years old or above
- •Patients with symptoms of urgency frequency and/or urge incontinence and urodynamically proven DHIC (defined by the ICS recommendation as: spontaneous detrusor contraction occurring during bladder filling phase or occurring before uninhibited detrusor contraction voiding at bladder capacity of less than 350ml in the urodynamic study, and has postvoid residual of more than 100ml but less than 250ml)
- •Free of active urinary tract infection
- •Free of bladder outlet obstruction on enrollment
- •Free of overt neurogenic bladder dysfunction
- •Having been treated with antimuscarinic agents for at least 1 months without effect or with intolerable adverse effects
- •Patient or his/her legally acceptable representative has signed the written informed consent form
排除标准
- •Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
- •Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- •Patients with bladder outlet obstruction on enrollment
- •Patients with postvoid residual > 250ml
- •Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
- •Patients have laboratory abnormalities at screening including:
- •ALT> 3 x upper limit of normal range AST> 3 x upper limit of normal range Patients have abnormal serum creatinine level > 2 x upper limit of normal range
- •Patients with any contraindication to be urethral catheterization during treatment
- •Patients with any other serious disease considered by the investigator not in the condition to enter the trial
- •Patients participated investigational drug trial within 1 month before entering this study
研究组 & 干预措施
Group A: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment
干预措施: Botulinum toxin A (Drug)
Group B: Botulinum toxin A
BoNT-A 100 units in normal saline 10ml, suburothelial injection 50 U in 10 sites and 50 U urethral injections in 5 sites
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
Net change of the Patients Perception of Bladder Condition (PPBC)
时间窗: Baseline and 3 months
Net change of the Patients Perception of Bladder Condition (PPBC, scored from 1 to 6) from baseline to 3 months after the treatment day. Safety: 1. Local adverse event incidences (hematuria, micturition pain, urinary tract infection (UTI), urinary retention) 2. Systemic adverse events. Safety: Systemic adverse events
次要结局
- Net change of the bladder capacity(Baseline and 3 months)
- Net change of the voiding frequency at daytime(Baseline and 3 months)
- Net change of the International Prostate Symptom Score (IPSS)(Baseline and 3 months)
- Net change of the presence of detrusor overactivity(Baseline and 3 months)
- Net change of the first sensation of bladder filling(Baseline and 3 months)
- Net change of the cystometric bladder capacity(Baseline and 3 months)
- Net change of the first sensation of voided volume(Baseline and 3 months)
- Net change of the voiding frequency at night time(Baseline and 3 months)
- Net change of voiding urgency severity score(Baseline and 3 months)
- Net change of the urge sensation(Baseline and 3 months)
- Net change of the first sensation of detrusor pressure(Baseline and 3 months)
- Net change of the maximum flow rate(Baseline and 3 months)
- Net change of the postvoid residual volume(Baseline and 3 months)
- Net change of the first sensation of bladder compliance(Baseline and 3 months)
研究者
Hann-Chorng Kuo
Director of Urology
Buddhist Tzu Chi General Hospital