Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
研究概览
简要总结
Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.
The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.
详细描述
In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.
The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).
The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.
The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.
The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Localized intermediate-risk or high-risk prostate cancer cT3
- •Gleason score ≥ 7 (3+4 and/or 4+3) and/or
- •PSA ≥ 20 ng/ml
- •intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).
排除标准
- •IIEF < 21
- •Operations in the past 6 months which could limit the erectile function
- •Erectile dysfunction in the history or current medication for erectile dysfunction
- •Current involvement in another comparable study.
结局指标
主要结局
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
时间窗: 24 months
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(24 months)