Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
2012年11月16日 更新者:Allergan
The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.
研究概览
研究类型
介入性
注册 (实际的)
380
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Lower urinary tract symptoms due to benign prostatic hyperplasia
- Enlarged prostate volume by rectal ultrasound
Exclusion Criteria:
- Previous prostate surgery
- Previous or current diagnosis of prostate cancer
- Use of other medications for the treatment of prostatic hyperplasia
- Urinary tract infection
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:botulinum toxin Type A 300 U
Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
|
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
其他名称:
|
实验性的:botulinum toxin Type A 200 U
Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
|
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
其他名称:
|
实验性的:botulinum toxin Type A 100 U
Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
|
Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.
其他名称:
|
安慰剂比较:Placebo (Normal Saline)
Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
|
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
大体时间:Baseline, Week 12
|
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index.
The questionnaire consists of seven items.
The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks.
The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms).
A negative change from baseline indicates improvement.
|
Baseline, Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
大体时间:Baseline, Week 72
|
The International Prostate Symptom Score is a disease-specific outcome measure based on the American Urological Association Symptom Index.
The questionnaire consists of seven items.
The patient evaluates their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks.
The total symptom score can range from 0 (no symptoms) to 35 (most severe symptoms).
A negative change from baseline indicates improvement.
|
Baseline, Week 72
|
Change From Baseline in Peak Urine Flow Rate
大体时间:Baseline, Week 12, Week 72
|
Urinary flow was determined by uroflowmetry at baseline and various time-points during the study.
An increase from baseline indicates improvement.
|
Baseline, Week 12, Week 72
|
Change From Baseline in Total Prostate Volume
大体时间:Baseline, Week 12, Week 72
|
Measurement of the prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study.
The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523.
A negative change from baseline indicates improvement.
|
Baseline, Week 12, Week 72
|
Change From Baseline in Transitional Zone Prostate Volume
大体时间:Baseline, Week 12, Week 72
|
Measurement of the transitional zone prostate volume was performed via transrectal ultrasound at baseline and various time-points during the study.
The prostate gland was scanned and the volume was calculated using the formula: Volume (mL) = length × width × height × 0.523.
A negative change from baseline indicates improvement.
|
Baseline, Week 12, Week 72
|
Change From Baseline in Post-Void Residual
大体时间:Baseline, Week 2, Week 12, Week 72
|
Post-void residual urine volume was assessed by bladder scan or ultrasound on all participants at baseline and various time-points during the study.
After voiding, any residual urine volume in the bladder was measured.
A negative change from baseline indicates improvement.
|
Baseline, Week 2, Week 12, Week 72
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change From Baseline in the International Index of Erectile Function (IIEF) Questionnaire Erectile Function Domain
大体时间:Baseline, Week 12, Week 72
|
The IIEF is a 15-item questionnaire filled out by the patient to assess erectile function over the past 4 weeks that contains five domains.
The score for the erectile function domain is the sum of scores for Questions 1, 2, 3, 4, 5 and 15 for a total possible score of 1 to 30.
A higher score indicates a better outcome.
A positive change from baseline indicates improvement.
|
Baseline, Week 12, Week 72
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年12月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2006年1月31日
首先提交符合 QC 标准的
2006年1月31日
首次发布 (估计)
2006年2月1日
研究记录更新
最后更新发布 (估计)
2012年12月17日
上次提交的符合 QC 标准的更新
2012年11月16日
最后验证
2012年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
botulinum toxin Type A的临床试验
-
University of NebraskaInCor Heart Institute; VU University of Amsterdam完全的
-
David BartlettNational Cancer Institute (NCI)完全的
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)招聘中