MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4
研究概览
简要总结
The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.
详细描述
MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement
- •Subjects are 18-48 months status-post radical prostatectomy
- •Subjects have any degree of erectile dysfunction based on IIEF questionnaire
- •Age 40 - 70 at study commencement
- •Diagnosed with low/intermediate-risk prostate cancer:
- •PSA < 20 ng/ml
- •Gleason score =< 8
- •Prostate Cancer stage =< T3a
- •Normal pre-radical prostatectomy erectile function (IIEF >=26) or equivalent response on EPIC
- •Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain <=25)
- •Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening
- •Able to understand and complete patient questionnaires
- •Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)
- •Able to consent to participate
- •Documented written informed consent from both patient and his female partner
排除标准
- •Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis
- •Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak)
- •Tumor upstaging beyond T3a
- •Incomplete / sub-total nerve sparing on either side
- •Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy
- •Prior receipt of androgen deprivation therapy
- •Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator
研究组 & 干预措施
MED3000 topical gel treatment
All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.
干预措施: MED3000 topical gel (Device)
结局指标
主要结局
Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4
时间窗: 12 weeks
To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it met MCID criteria of change of mean 4 \[IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale
次要结局
- Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)(12 weeks)
- Adverse Events of MED3000 Topical Gel(12 weeks)
- Change From Baseline in All Domains of the IIEF.(12 weeks)
研究者
Martin Kathrins, M.D.
Assistant Professor of Surgery
Brigham and Women's Hospital