NCT01742962

Prevalence of Neglected Side Effects to Radical Prostatectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 396 (actual)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Radical prostatectomy for prostate cancer	Prior treatment with open or robot assisted laparoscopic prostatectomy.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2012-12-06
• Last updated: 2014-07-02

Locations

1 site across 1 country: Denmark