An observational study in Prostate Cancer, sponsored by Copenhagen University Hospital at Herlev. Completed at 1 site in Denmark. Open to male participants. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Copenhagen University Hospital at Herlev · Observational
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:
In addition information on a range of demographics and information on the patient´s erectile function will be collected.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 396 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Copenhagen University Hospital at Herlev is the lead sponsor of 76 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Post prostatectomy patients operated at Copenhagen University Hospital in Herlev, Denmark.
Exclusion Criteria:
Prior treatment with open or robot assisted laparoscopic prostatectomy.
Procedure: Radical prostatectomy for prostate cancer
Prior treatment with open or robot assisted laparoscopic prostatectomy.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Incidence of lower urinary tract infections following radical prostatectomy
We want to know how large a percentage of patients treated with radical prostatectomy are experiencing a lower urinary tract infection post surgery.
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Incidence of alcohol related incontinence in patients undergone radical prostatectomy
Does alcohol exacerbate incontinence symptoms?
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Impact of radical prostatectomy on the patients libido.
Does radical prostatectomy influence patients libido?
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Patterns of use and discontinuation of use of aids for erectile dysfunction.
A series of questions will investigate the patients use of aids for erectile dysfunction and reasons for discontinuation.
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Patient satisfaction with treatment.
Assessed by a global satisfaction scale, and an evaluation of fulfillment of expectations prior to treatment.
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
How do the patients gather knowledge of their disease?
From which sources do the patients get their knowledge of prostate cancer.
Time frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Copenhagen University Hospital at Herlev