Prevalence of Neglected Side Effects to Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01742962
First received: December 4, 2012
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Radical prostatectomy for prostate cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Neglected Side Effects to Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Incidence of Urinary incontinence in relation to sexual activity measured as percentage of the population. [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    The percentage of the study population experiencing urinary incontinence when engaging in sexual activity.

  • Incidence of altered perception of orgasm measured as percentage of the population. [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    The percentage of the study population experiencing altered perception of orgasm.

  • Incidence of orgasm related pain measured as percentage of the population. [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    The percentage of the study population experiencing orgasm related pain.

  • Incidence of impairing deviations or loss of length of the penis measured as percentage of the population. [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    The percentage of the study population experiencing impairing deviations or loss of length of the penis.


Other Outcome Measures:
  • Incidence of lower urinary tract infections following radical prostatectomy [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    We want to know how large a percentage of patients treated with radical prostatectomy are experiencing a lower urinary tract infection post surgery.

  • Incidence of alcohol related incontinence in patients undergone radical prostatectomy [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    Does alcohol exacerbate incontinence symptoms?

  • Impact of radical prostatectomy on the 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. ] [ Designated as safety issue: No ]
    Does radical prostatectomy influence patients libido?

  • Patterns of use and discontinuation of use of aids for erectile dysfunction. [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    A series of questions will investigate the patients use of aids for erectile dysfunction and reasons for discontinuation.

  • Patient satisfaction with 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. ] [ Designated as safety issue: No ]
    Assessed by a global satisfaction scale, and an evaluation of fulfillment of expectations prior to treatment.

  • How do the patients gather knowledge of their disease? [ Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy. ] [ Designated as safety issue: No ]
    From which sources do the patients get their knowledge of prostate cancer.


Enrollment: 396
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Radical prostatectomy for prostate cancer
Prior treatment with open or robot assisted laparoscopic prostatectomy.
Procedure: Radical prostatectomy for prostate cancer
Prior treatment with open or robot assisted laparoscopic prostatectomy.

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Post prostatectomy patients operated at Copenhagen University Hospital in Herlev, Denmark.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742962

Locations
Denmark
Copenhagen University Hospital in Herlev, Denmark
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Anders U. K. Frey, Stud.Med. Copenhagen University Hospital in Herlev, Denmark
Study Director: Mikkel M. Fode, Dr. Copenhagen University Hospital in Herlev, Denmark
Study Chair: Jens Sønksen, Professor Copenhagen University Hospital in Herlev, Denmark
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01742962     History of Changes
Other Study ID Numbers: 2007-58-0015 / HEH.750.19-31, H-2-2012-FSP43
Study First Received: December 4, 2012
Last Updated: July 1, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Copenhagen University Hospital at Herlev:
Prostatectomy
Prostate cancer
Orgasm
Urinary incontinence
Climacturia(orgasm related urinary incontinence)
Penis
Dysorgasmia (pain in relation to orgasm)
Pain
Anorgasmia
Penile shortening
Erectile dysfunction

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014