Penile Length Restoration in Men With Diabetes Mellitus, Type II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Penile Length Change Between Baseline and Month 6
研究概览
简要总结
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.
详细描述
Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. One of these sexual dysfunctions includes diminished penile length. It is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. Penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. To accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type II will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The provider and outcome assessor will be blinded to the patient's study arm for all length assessments. Additionally, the assessor will be blinded to prior length measurements.
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
- •Men with Diabetes Mellitus, Type II
排除标准
- •Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
- •Loss of fingers / toes.
- •CKD Stage IV or greater.
- •Retinopathy
- •Myocardial infarction.
- •Cerebrovascular accident.
- •Indwelling penile prosthesis or prior history of penile prosthesis.
- •Peyronie's disease at baseline.
研究组 & 干预措施
Group 1: Control
No treatment will be administered for the entirety of the study (6 months)
Group 2: Treatment
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
干预措施: RestoreX PTT - 3 months (Device)
Group 3: Treatment
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
干预措施: RestoreX PTT - 6 months (Device)
Group 4: Treatment
PTT for 30 min 2x day x 6 months
干预措施: RestoreX PTT - 6 months (Device)
结局指标
主要结局
Penile Length Change Between Baseline and Month 6
时间窗: Baseline to 6 months
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
次要结局
- Number of Participants With Adverse Events With Use of RestoreX(3 and 6 months post-prostatectomy)
- Patient Compliance With Traction Therapy(6 months)
- Patient Reported Satisfaction With Traction Therapy at 6 Months.(6 months)
- Number of Participants With De-novo Peyronie's Disease Development(6 months)
- Subjective Comparison of Changes in Penile Length(6 months)
- Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.(Baseline and 6 months)
研究者
Matthew (Matt) J. Ziegelmann
Principal Investigator
Mayo Clinic