Clinical trial NCT01742962: Prevalence of Neglected Side Effects to Radical Prostatectomy
Official title: Prevalence of Neglected Side Effects to Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostatectomy
Prostate cancer
Orgasm
Urinary incontinence
Climacturia(orgasm related urinary incontinence)
Penis
Dysorgasmia (pain in relation to orgasm)
Pain
Anorgasmia
Penile shortening
Erectile dysfunction
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 396
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Post prostatectomy patients operated at Copenhagen University Hospital in Herlev, Denmark.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Urinary incontinence in relation to sexual activity measured as percentage of the population.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Incidence of altered perception of orgasm measured as percentage of the population.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Incidence of orgasm related pain measured as percentage of the population.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Incidence of impairing deviations or loss of length of the penis measured as percentage of the population.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Secondary outcomes:
Other outcomes:
measure: Incidence of lower urinary tract infections following radical prostatectomy
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Incidence of alcohol related incontinence in patients undergone radical prostatectomy
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Impact of radical prostatectomy on the patients libido.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Patterns of use and discontinuation of use of aids for erectile dysfunction.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: Patient satisfaction with treatment.
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
measure: How do the patients gather knowledge of their disease?
timeFrame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital in Herlev, Denmark
Study officials:
affiliation: Copenhagen University Hospital in Herlev, Denmark
name: Anders U. K. Frey, Stud.Med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital in Herlev, Denmark
name: Mikkel M. Fode, Dr.
role: STUDY_DIRECTOR
affiliation: Copenhagen University Hospital in Herlev, Denmark
name: Jens Sønksen, Professor
role: STUDY_CHAIR
References: