Prevalence of Neglected Side Effects to Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Prevalence of Neglected Side Effects to Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742962
• Other study ID #: 2007-58-0015 / HEH.750.19-31
• Secondary ID: H-2-2012-FSP43
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: July 1, 2014
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy for prostate cancer
Prior treatment with open or robot assisted laparoscopic prostatectomy.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital in Herlev, Denmark	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of lower urinary tract infections following 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.	No
Other	Incidence of alcohol related incontinence in patients undergone 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.	No
Other	Impact of radical prostatectomy on the patients libido.	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.	No
Other	Patterns of use and discontinuation of use of aids for erectile dysfunction.	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.	No
Other	Patient satisfaction with treatment.	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.	No
Other	How do the patients gather knowledge of their disease?	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.	No
Primary	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.	A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.	No
Primary	Incidence of altered perception of orgasm measured as percentage of the population.	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.	No
Primary	Incidence of orgasm related pain measured as percentage of the population.	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.	No
Primary	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.	A momentary exploratory analysis of the problem in the study population, who are between 3 months and 3 years post radical prostatectomy.	No