Prostate CancerNCT01742962
Prevalence of Neglected Side Effects to Radical Prostatectomy
An observational study of Prostate Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical prostatectomy for prostate cancer
- Type of treatment
- Surgery or procedure
- How many people
- 396 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Post prostatectomy patients operated at Copenhagen University Hospital in Herlev, Denmark.
Who may be able to join
- 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.
Who cannot join
- Incontinence associated with sexual activity Prior to surgery
- Peyronies disease Prior to surgery
- Orgasm related pain Prior to surgery
- Anorgasmia Prior to surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital in Herlev, Denmark
Herlev, Herlev, 2730
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Radical prostatectomy for 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
- Medical subject headings
- Prostatic Neoplasms, Orgasm, Urinary Incontinence, Pain, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomy for prostate cancerProcedure or surgery
Prior treatment with open or robot assisted laparoscopic prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Radical prostatectomy for prostate cancer | Prior treatment with open or robot assisted laparoscopic prostatectomy. Receives: Procedure: Radical prostatectomy for prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders U. K. Frey, Stud.Med., Principal investigator, Copenhagen University Hospital in Herlev, DenmarkMikkel M. Fode, Dr., Study director, Copenhagen University Hospital in Herlev, DenmarkJens Sønksen, Professor, Study chair, Copenhagen University Hospital in Herlev, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742962
- Sponsor's protocol ID
- 2007-58-0015 / HEH.750.19-31
- Other IDs
- H-2-2012-FSP43
- Status last verified
- Jul 2014
- First submitted
- 4 Dec 2012
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Neglected Side Effects to Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01742962
- Acronym / sponsor ID
- 2007-58-0015 / HEH.750.19-31
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy, Prostate cancer, Orgasm, Urinary incontinence, Climacturia(orgasm related urinary incontinence), Penis, Dysorgasmia (pain in relation to orgasm), Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomy for prostate cancer | – | Procedure: Radical prostatectomy for prostate cancerPrior treatment with open or robot assisted laparoscopic prostatectomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post prostatectomy patients operated at Copenhagen University Hospital in Herlev, Denmark.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Incontinence associated with sexual activity Prior to surgery
- Peyronies disease Prior to surgery
- Orgasm related pain Prior to surgery
- Anorgasmia Prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomy for prostate cancerPrior treatment with open or robot assisted laparoscopic prostatectomy. | Procedure or surgery | Radical prostatectomy for prostate cancer |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders U. K. Frey, Stud.Med. principal investigator
Copenhagen University Hospital in Herlev, Denmark
Mikkel M. Fode, Dr. study director
Copenhagen University Hospital in Herlev, Denmark
Jens Sønksen, Professor study chair
Copenhagen University Hospital in Herlev, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.