Prevalence of Neglected Side Effects to Radical Prostatectomy

July 1, 2014 updated by: Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Copenhagen University Hospital in Herlev, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The percentage of the study population experiencing urinary incontinence when engaging in sexual activity.
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing altered perception of orgasm.
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing orgasm related pain.
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
The percentage of the study population experiencing impairing deviations or loss of length of the penis.
A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
We want to know how large a percentage of patients treated with radical prostatectomy are experiencing a lower urinary tract infection post surgery.
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
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Does alcohol exacerbate incontinence symptoms?
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Does radical prostatectomy influence patients libido?
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
A series of questions will investigate the patients use of aids for erectile dysfunction and reasons for discontinuation.
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.
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Assessed by a global satisfaction scale, and an evaluation of fulfillment of expectations prior to treatment.
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?
Time Frame: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
From which sources do the patients get their knowledge of prostate cancer.
A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-58-0015 / HEH.750.19-31
  • H-2-2012-FSP43 (OTHER: Denmark: The Regional Committee on Biomedical Research Ethics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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