Prevalence of Neglected Side Effects to Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevalence of Neglected Side Effects to Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radical prostatectomy for prostate cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Incontinence associated with sexual activity Prior to surgery Peyronies disease Prior to surgery Orgasm related pain Prior to surgery Anorgasmia Prior to surgery
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radical prostatectomy for prostate cancer<br>Prior treatment with open or robot assisted laparoscopic prostatectomy. | Procedure: Radical prostatectomy for prostate cancer<br>* Prior treatment with open or robot assisted laparoscopic prostatectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Urinary incontinence in relation to sexual activity measured as percentage of the population. | The percentage of the study population experiencing urinary incontinence when engaging in sexual activity. | A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. | 
| Incidence of altered perception of orgasm measured as percentage of the population. | The percentage of the study population experiencing altered perception of orgasm. | A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. | 
| Incidence of orgasm related pain measured as percentage of the population. | The percentage of the study population experiencing orgasm related pain. | A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. | 
| Incidence of impairing deviations or loss of length of the penis measured as percentage of the population. | The percentage of the study population experiencing impairing deviations or loss of length of the penis. | A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatectomy, Prostate cancer, Orgasm, Urinary incontinence, Climacturia(orgasm related urinary incontinence), Penis, Dysorgasmia (pain in relation to orgasm), Pain, Anorgasmia, Penile shortening, Erectile dysfunction