Treatment Response to Xiaflex Based on Ultrasound Characterization of Plaque for Men With Peyronie's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).
研究概览
简要总结
The purpose of this research study is to develop a database of patients with Peyronie's disease who are treated at the University of Miami. The collected data will help the researchers to better understand Peyronie's disease and its response to therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≥18 years
- •Able to provide informed consent
- •A stable relationship for ≥3 months
- •PD symptoms with evidence of stable disease as determined by the investigator
- •Penile curvature deformity of >30° to <90°
- •Has not had previous surgery for PD
- •Has not had previous therapy with Xiaflex for PD
排除标准
- •Ventral plaque
- •Active phase PD
- •Actively on anticoagulation during time frame of injections
- •Aspirin 81mg will be eligible for therapy
- •Hour glass deformity
- •Previous allergic reaction to Xiaflex
- •Unwilling to participate
- •Medically unfit for sexual intercourse as deemed by the principal investigator
- •Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI
结局指标
主要结局
Penile pain evaluation in Peyronie's Disease Questionnaire (PDQ).
时间窗: 52 weeks
The PDQ is highly responsive to treatment-related change in men with PD. It measures penile pain in patients with PD. It is intended for men who have had vaginal intercourse in the past 3 months, which evaluate the levels of pain or discomfort based on last erection or vaginal intercourse. The range of scores is from 0-30 points, with higher scores signifying greater penile pain or discomfort.
Goniometer measurement to determine degree of curvature of PD.
时间窗: 52 weeks
Evaluate the total degree change of curvature improvement after treatment with Xiaflex measured by goniometer, an instrument that measures the angle of the curvature to determine the degree of the PD.
Psychosexual changes in Peyronie's Disease Questionnaire (PDQ).
时间窗: 52 weeks
The PDQ is highly responsive to treatment-related change in men with PD. It is self-administered, that measures psychosexual consequences after the presentation of PD. It is intended for men who have had vaginal intercourse in the past 3 months. The range of scores is from 0-24 points, with higher scores signifying greater psychosexual consequences from PD.
次要结局
- International Index of Erectile Function (IIEF) Scores(52 weeks)
研究者
Ranjith Ramasamy, MD
Director of Male Fertility and Andrology, University of Miami
University of Miami