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Prevalence of Neglected Side Effects to Radical Prostatectomy


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N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Prevalence of Neglected Side Effects to Radical Prostatectomy


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Incidence of Urinary incontinence in relation to sexual activity measured as percentage of the population.

Outcome Description:

The percentage of the study population experiencing urinary incontinence when engaging in sexual activity.

Outcome Time Frame:

A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.

Safety Issue:

No

Principal Investigator

Anders U. K. Frey, Stud.Med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Copenhagen University Hospital in Herlev, Denmark

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

2007-58-0015 / HEH.750.19-31

NCT ID:

NCT01742962

Start Date:

December 2012

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • Prostatectomy
  • Prostate cancer
  • Orgasm
  • Urinary incontinence
  • Climacturia(orgasm related urinary incontinence)
  • Penis
  • Dysorgasmia (pain in relation to orgasm)
  • Pain
  • Anorgasmia
  • Penile shortening
  • Erectile dysfunction
  • Prostatic Neoplasms

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