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Completed

NCT Number: NCT01742962

Prevalence of Neglected Side Effects to Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Behavior Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Orgasm Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Sexual Behavior Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Sex eligibility

Male

Study type

Observational

Primary location

Copenhagen University Hospital in Herlev, Denmark

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radical prostatectomy for prostate cancer

Procedure

Prior treatment with open or robot assisted laparoscopic prostatectomy.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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?

  3. 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?

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2012
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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