Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms.
研究概览
简要总结
Patients with longstanding obstructive lower urinary tract symptoms (LUTS) due to benign prostatic hypertrophy (BPH) can also develop symptoms of overactive bladder syndrome (OAB). Transurethral resection of the prostate (TURP) and Transurethral Waterjet Ablation of the Prostate (Aquablation) are amongst the gold standard surgical treatments for BPH. However, in the immediate post-operative period, TURP and Aquablation can also include OAB-like symptoms, including urinary frequency and urgency. For men with baseline OAB symptoms, this initial worsening of symptoms can be distressing.
Botox is an FDA approved medication with on-label indications to treat overactive bladder.
The purpose of this study is to evaluate the outcomes of men who have Botox concurrent with their TURP or Aquablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male >= 18 years of age and being scheduled to undergo TURP or Aquablation and Botox procedure.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Non-English speaking
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •History of receiving Botox in the bladder, within the previous 12 months.
研究组 & 干预措施
Observational Group
This group will contain men (>=18 years) and will be scheduled to undergo TURP or Aquablation and Botox procedure.
干预措施: Survey using a questionnaire. (Other)
结局指标
主要结局
To identify whether concurrent Botox and TURP or Aquablation are effective at reducing post-operative irritative voiding symptoms.
时间窗: 4 months
This will be measured using Postoperative Urinary Retention (POUR): At 1 week post-operative visit for trial of void to assess for rates of postoperative urinary retention. At 4 and 12 week post-operative visits for post void residual assessment
次要结局
- To identify whether concurrent Botox and TURP or Aquablation lead to longer hospitalizations.(4 months)
- To identify whether concurrent Botox and TURP or Aquablation lead to higher rates of urinary retention.(4 months)
研究者
Will Fuller
Principal Investigator
Benaroya Research Institute