Ejaculatory-Sparing HoLEP vs Standard HoLEP
Ejaculatory-sparing Holmium Laser Enucleation of the Prostate (HoLEP) vs Standard HoLEP: a Randomized Controlled Trial
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Alyssa McDonald, MPH
- 电话号码:312-695-8146
- 邮箱:alyssa.mcdonald@northwestern.edu
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Northwestern University
-
首席研究员:
- Amy E Krambeck, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients who are sexually active with antegrade ejaculation who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms.
Exclusion Criteria:
- Patients with pre-existing retrograde ejaculation
- Patients who are not sexually active
- Patients with indwelling urinary catheter prior to surgery, neurological disease, or history of prior prostatic/urethral surgery that may impact ejaculation
- Patients who lack decisional capacity
- Patients unable to read/speak English
学习计划
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Standard HoLEP
HoLEP procedure performed using standard care technique.
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有源比较器:ES-HoLEP
HoLEP procedure performed using ejaculatory-sparing HoLEP technique.
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The ejaculatory sparing technique involves sparing the distal apex of the prostate in particular the anterior portion of the prostate which will allow for coaptation necessary for antegrade ejaculation.
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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 |
|---|---|---|
|
Incidence of retrograde ejaculation
大体时间:1 year
|
Patient reported incidence of experiencing retrograde ejaculation
|
1 year
|
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Ejaculatory satisfaction
大体时间:1 year
|
Patient reported satisfaction of ejaculation using Male Sexual Health Questionnaire - Ejaculatory Dysfunction (MSHQ-EjD) questionnaire. The MSHQ-EjD-SF evaluates the following parameters in regards to ejaculation: Frequency, Force, Volume and Bother (How much are you bothered by any ejaculation difficulties) on a 6-point Likert scale (typically scored 0 to 5). Interpretation: Higher scores indicate better ejaculatory function, while lower scores denote dysfunction and a greater level of personal distress regarding one's ejaculatory function. |
1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sexual satisfaction
大体时间:1 year
|
Patient reported sexual satisfaction using the Sexual Health Inventory for Men (SHIM) questionnaire. The Sexual Health Inventory for Men (SHIM) contains 5 questions that is individually scored on a scale of 0 to 5. The SHIM score is calculated by adding up the scores of the 5 individual questions. Interpretation: Higher scores indicate better erectile function, while lower scores denote erectile dysfunction. A total score of 21 or less indicates that erectile dysfunction is present and should be addressed with a healthcare provider. |
1 year
|
|
Urinary satisfaction
大体时间:1 year
|
Patient reported urinary satisfaction using the International Prostate Symptom Score (IPSS) questionnaire. The International Prostate Symptom Score (IPSS) is calculated by asking patients to rate 7 urinary symptoms over the past month on a scale from 0 to 5. These scores are simply added together to yield a total symptom severity score ranging from 0 to 35. An 8th question measures overall Quality of Life (QoL) but is not factored into the numerical total. Interpretation: the total score range is from 0 to 35. The total score indicates symptom severity: 0-7: Mildly symptomatic 8-19: Moderately symptomatic 20-35: Severely symptomatic |
1 year
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Urinary satisfaction
大体时间:1 year
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Patient reported urinary satisfaction using the Michigan Incontinence Symptom Index (M-ISI) questionnaires. The M-ISI (Michigan Incontinence Symptom Index) questionnaire is a 10-item clinical tool used to evaluate the severity of urinary incontinence and how much it bothers the patient. It is calculated by assigning scores (0 to 4) to each answer and summing them across two primary domains. Total M-ISI Severity Domain (Items 1-8): Sum of the scores for the first 8 questions. This evaluates incontinence subdomains (Stress Urinary Incontinence, Urgency Urinary Incontinence, and Pad Use). Possible score range 0 to 32. Bother Domain (Items 9-10): Sum of the scores for questions 9 and 10. This measures the emotional and physical impact of the leakage. Possible score range 0 to 8. Interpretation: Higher scores indicate the individual is likely incontinent or has experience with incontinence. |
1 year
|
合作者和调查者
调查人员
- 首席研究员:Amy E Krambeck, MD、Northwestern University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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