Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,076
- 试验地点
- 30
- 主要终点
- Patient Satisfaction score
研究概览
简要总结
Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).
详细描述
This will be a prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs). The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the European Association of Urology (EAU) Section of Genitourinary Reconstructive Surgeons (ESGURS) to all its members, along with other urologists undertaking these procedures.
There will be no restriction on the number of patients enrolled per centre as long as they are consecutive. The aim is to have a long term collection of the dataset from as many centres as possible. An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed 1 and 2 years after recruitment of the first patient by a nominated steering committee. Thereafter, the evaluations will be performed every 2 years until the end of Registry (10 years after the first patient was enrolled).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male patient undergoing a surgical penile prosthesis implant for treatment of erectile dysfunction.
- •Participant is willing and able to give informed consent for participation in the Registry and is able to complete the questionnaires.
排除标准
- •Participating center is unable to contribute consecutive patients.
结局指标
主要结局
Patient Satisfaction score
时间窗: at week 12, year 1, 2, 4, 6, 8 and 10 after surgery
Patient Satisfaction score is defined as the mean patient satisfaction score as indicated by the Modified Patient EDITS Questionnaire. All items on the Patient EDITS will be scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The mean satisfaction score for each patient will be calculated. To place scores in an easily interpretable metric, each mean score will be multiplied by 25 so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 extremely high treatment satisfaction).
次要结局
- Overall time being satisfied with treatment since implantation(up to 10 years post surgery)
- Partner Satisfaction score(at week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- Patient satisfaction rate(at week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- Partner satisfaction rate(at week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- International Index of Erectile Function - 5 (IIEF short form/SHIM) questionnaire(at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- Sexual Encounter Profile (SEP) questions 2 and 3(at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- EQ-5D-5L quality of life questionnaire(at baseline, week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire(at week 12, year 1, 2, 4, 6, 8 and 10 after surgery)
- Complications(during surgery and up to 10 years after surgery)
- Immediate Postoperative complications(until 2 weeks after surgery)
- Time of first activation, first cycling, first use, first intercourse, first orgasm, if applicable(up to 10 years post surgery)
- Time being revision-free(up to 10 years post surgery)
- Revision-free rate(at 1, 2, 4, 6, 8 and 10 years of Registry follow-up)