Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 16
- 主要终点
- The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping.
研究概览
简要总结
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
详细描述
Erectile dysfunction (ED) is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners. Incidence of ED increases with age and is associated with depression, obesity, diabetes mellitus, hypertension, cardiovascular disease and benign prostatic hyperplasia. ED is diagnosed with symptoms of (1) inability to attain or sustain a penile erection during sexual activity and (2) a reduction of penile rigidity in >75% of sexual encounters during six months period. ED is estimated to affect approximately 52% of men in age of 40 to 70 years. It is projected in 2025, the worldwide ED prevalence of about 322 million. ED usually has organic causes, such as damage of arteries, smooth muscle and fibrous tissue. This results in impairment of blood flow to and from penis due to diabetes, renal disease, atherosclerosis and vascular disease.
Management of ED involves lifestyle modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection or topical application of vasoactive drugs have also been studied. The first inflatable penile prosthesis was introduced in 1973, and current models of inflatable penile prostheses include the AMS 700 series, and Coloplast Titan device. A patient-activated inflatable penile prosthesis (IPP) provides patients with a means to achieve dependable spontaneity for intercourse.
Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥22 years of age.
- •Diagnosed with erectile dysfunction (impotence).
- •Agree to receive Infla10® three-piece IPP as an ED treatment.
- •Willing to complete all protocol required for follow-up visits and tests.
排除标准
- •Contraindication to general anesthesia.
- •Known allergy or sensitivity to product materials as indicated in the device labeling.
- •Previous penile prosthesis or prior enlargement surgeries
- •Diagnosed penile sensory neuropathy.
- •Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
- •Patients who are receiving chemotherapy at the time of enrolment.
- •Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
- •Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
- •Uncontrolled diabetes (HbA1c ≥ 9.0% [≈75 mmol/mol], measured within 90 days prior to surgery.
- •Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
- •Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
- •Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
- •Lacking manual dexterity or mental abilities necessary to operate the device.
- •Expected life expectancy < two years.
- •Unwilling or unable to sign the Informed Consent.
- •Unwilling or unable to comply with the follow-up study requirements.
- •Psychogenic erectile dysfunction
- •Currently participating in an investigational drug or another investigational device exemption (IDE) study.
- •The cognitively challenged subjects and subjects with any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
- •Incarcerated subjects
- •Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.
研究组 & 干预措施
Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
干预措施: Rigicon Infla10® Inflatable Penile Prosthesis (IPP) (Device)
结局指标
主要结局
The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping.
时间窗: 12 months
Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.
The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.
时间窗: 12 months
The objective axial rigidity test will use a calibrated axial-rigidity device to measure vertical displacement of the fully inflated penis under a standardized 650-gram load. ≤15 mm displacement will be counted as a "pass". Success will be concluded if the two-sided 95 percent confidence interval for the 12-month success proportion has its lower bound strictly greater than the pre-specified performance goal in the statistical plan.
The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v5.0 and IPP-specific mapping.
时间窗: 12 months
Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.
次要结局
- Percentage of patients free from revision or explant surgeries at 12 months.(12 months)
- International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score(Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.)
- Rosenberg Self-Esteem Scale (RSES) Total Score(Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.)
- Adverse Events(36 months)