Prevalence of Neglected Side Effects to Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Incidence of altered perception of orgasm measured as percentage of the population.
研究概览
简要总结
The purpose of this exploratory data collection is to strengthen our knowledge of some of the rarer distresses following surgical removal of the prostate. In general these are:
- Side effects related to sexuality, including:
- Altered perception of orgasm,
- Orgasm associated pain,
- Penile shortening and deformity.
- Side effects related to urinary incontinence.
- Urinary tract infection after operation.
- Influence of distress on sexual quality of life.
- Influence of distress on the patient´s sex drive.
In addition information on a range of demographics and information on the patient´s erectile function will be collected.
详细描述
Approximately 1 out of 6 men will, at some point of their life become diagnosed with prostate cancer. Treatment options included medication therapy, radiation therapy, and surgery. This data collection aims to gather information on some of the lesser known distresses experienced by patients following surgical removal of the prostate gland.
Erectile dysfunction and urinary incontinence remain common, but thoroughly investigated side effects. Thus they will not be of primary interest here, but considered factors for correlation. During the last couple of years, a series of lesser known side effects have come to investigators attention. These include altered perception of orgasm, orgasm related pain, sexual-related urinary incontinence, and shortening -and impairing deviations of the penis. Few studies have investigated these side effects, and clear knowledge of why, and how often these problems arise, remain scarce. This study will contribute to that knowledge.
In addition, the questionnaire will include a series of exploratory questions, concerning lower urinary tract infections, treatment satisfaction, alcohol and urinary incontinence, reasons for abandoning treatment for erectile dysfunction, and an assessment of libido prior to and after radical prostatectomy.
The data collection will include approximately 400 patients from the department of urology at the University Hospital in Herlev, Copenhagen, Denmark. A questionnaire will be sent to patients together with a stamped addressed envelope in order to optimize the response rate. Results will be kept in a separate database from personal information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patient who have undergone radical prostatectomy at the department of urology, Copenhagen University Hospital, Herlev, between 3 months and 3 years before initiation of the study.
排除标准
- •Incontinence associated with sexual activity Prior to surgery
- •Peyronies disease Prior to surgery
- •Orgasm related pain Prior to surgery
- •Anorgasmia Prior to surgery
结局指标
主要结局
Incidence of altered perception of orgasm measured as percentage of the population.
时间窗: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing altered perception of orgasm.
Incidence of Urinary incontinence in relation to sexual activity measured as percentage of the population.
时间窗: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing urinary incontinence when engaging in sexual activity.
Incidence of orgasm related pain measured as percentage of the population.
时间窗: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing orgasm related pain.
Incidence of impairing deviations or loss of length of the penis measured as percentage of the population.
时间窗: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing impairing deviations or loss of length of the penis.
次要结局
未报告次要终点
