Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in symptom bother
研究概览
简要总结
The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.
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
- None
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
- •Diagnosed with PD
- •Palpable penile plaque
- •Dorsal, lateral, or dorsolateral penile curvature
- •Penile curvature > 30 degrees and < 90 degrees as measured using goniometer during objective curvature assessment
- •Non-calcified plaque or grade 1 calcification ("stippling", no shadowing) as determined by penile duplex Doppler ultrasound (PDDU)
- •"Stable PD symptoms' defined as PD symptom duration > 6-months or stable symptoms > 3-months
排除标准
- •Prior intralesional injections or surgery for PD.
- •Severe baseline penile pain.
- •Moderate or severe baseline ED based on IIEF-EF domain.
- •History of low intensity shockwave therapy for sexual dysfunction (ED or PD).
- •Ventral (downward) or ventrolateral penile curvature.
- •Moderate or severe (grade 2/3) plaque calcification as determined by PDDU.
- •Inability to achieve satisfactory erection rigidity at time of baseline curvature assessment.
研究组 & 干预措施
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
干预措施: Collagenase Clostridium Histolyticum (Drug)
Collagenase Clostridium Histolyticum with Low Intensity Shockwave Therapy
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection with low-intensity shockwave therapy (LiSWT).
干预措施: Storz Duolith LiSWT (Device)
Collagenase Clostridium Histolyticum
Subjects will receive Collagenase Clostridium Histolyticum (CCH) intralesional injection per standard of care.
干预措施: Collagenase Clostridium Histolyticum (Drug)
结局指标
主要结局
Change in symptom bother
时间窗: Baseline, 6 weeks
Measured using the validated Peyronie's Disease Questionnaire (PDQ) subdomain symptom bother. Four questions to evaluate pain or discomfort during vaginal intercourse: responses include "not at all bothered", "a little bit bothered" , "moderately bothered", "very bothered", "extremely bothered"
Change in Erectile Function Domain (IIEF-EF)
时间窗: Baseline, 6 weeks
Change in erectile function
时间窗: Baseline, 6 weeks
Measured using the International Index of erectile Function
Change in penetrative sexual intercourse
时间窗: Baseline, 6 weeks
Measured using self-reported question: "Over the past 4 weeks: When you attempted intercourse, how often were you able to penetrate (enter) your partner?" Responses include "no sexual activity", "almost never or never" , "a few times (less than half the time)", "sometimes (about half the time)", "Most times (more than half the time)", "almost always or always.
Surgical straightening intervention
时间窗: 6 weeks
Number of subjects to require surgical straightening
次要结局
未报告次要终点
研究者
Tobias S. Kohler, MD, MPH
Principal Investigator
Mayo Clinic