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Completed

NCT Number: NCT00335634

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

The purpose of this study is to explore patient and partner experiences with sexual dysfunction following radical prostatectomy, in order to understand its effects on sexual and non-sexual intimacy. This will enable us to provide assistance in the future to individuals experiencing similar circumstances.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etobicoke General Hospital, Etobicoke, Ontario, Canada

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About this study

We are studying the impact of sexual dysfunction following radical prostatectomy on patient and partners' experiences of intimacy. Research with men in post-radical prostatectomy recovery indicates 25%-75% experience sexual dysfunction. Many patients experience anxiety and distress related to sexual difficulties. These experiences may progress and result in long-term problems in the relationship between patients and their partners. Despite apparent levels of effectiveness, up to half of the patients who turn to sexually assistive aids after surgical removal of the prostate discontinue use of the aids within one year. Additionally, difficulties in communicating about sexual impairments can significantly interfere with the couples' ability to achieve successful adaptation. We are interested in studying patient and partner experiences with sexual dysfunction in order to understand its effects on sexual and non-sexual intimacy.

Participation in this study will involve completing 6 confidential face-to-face interviews on three separate occasions (3-6 months, 12-15 months, and 21-24 months post-surgery). On each occasion, participants will be required to take part in a "couple's" interview with his/her partner, as well as an individual interview. The interviews will provide participants with the opportunity to discuss the impact of sexual dysfunction on mood, thoughts, and communication with their partners. Demographic information will be collected at the initial interview. As well, at each of the 3 time points, participants will also be asked to complete a questionnaire package containing 6 psychological questionnaires. All questionnaires and interview material will be kept strictly confidential.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Radical prostatectomy treatment for prostate cancer at Princess Margaret Hospital or Etobicoke General Hospital
  • At least 3 months, but less than 6 months post-radical prostatectomy
  • Experience sexual dysfunction as a result of radical prostatectomy
  • Must have an intimate partner and be able to participate as a couple

Exclusion criteria

  • Detectable prostate specific antigen (PSA) post-radical prostatectomy
  • Patient or partner unable to speak English
  • Patient or partner unwilling to allow interviews to be recorded
  • Patient or partner unwilling to participate

Treatment and study plan

Primary outcomes

  1. Semi-Structured Interview - Patient

    Time frame: 3-6 months post-radical prostatectomy

  2. Semi-Structured Interview - Patient

    Time frame: 12-15 months post-radical prostatectomy

  3. Semi-Structured Interview - Patient

    Time frame: 21-24 months post-radical prostatectomy

  4. Semi-Structured Interview - Partner

    Time frame: 3-6 months post-radical prostatectomy

  5. Semi-Structured Interview - Partner

    Time frame: 12-15 months post-radical prostatectomy

  6. Semi-Structured Interview - Partner

    Time frame: 21-24 months post-radical prostatectomy

  7. Semi-Structured Interview - Couple

    Time frame: 3-6 months post-radical prostatectomy

  8. Semi-Structured Interview - Couple

    Time frame: 12-15 months post-radical prostatectomy

  9. Semi-Structured Interview - Couple

    Time frame: 21-24 months post-radical prostatectomy

Secondary outcomes

  1. The International Index of Erectile Function

    Time frame: 3-6 months post-radical prostatectomy

    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners

  2. Index of Sexual Life

    Time frame: 3-6 months post-radical prostatectomy

    Used to assess sexual desire and overall sexual satisfaction in female partners

  3. Dyadic Adjustment Scale

    Time frame: 3-6 months post-radical prostatectomy

    Used to measure couple distress

  4. Hospital Anxiety and Depression Scale

    Time frame: 3-6 months post-radical prostatectomy

    Used to measure anxiety and depression

  5. The International Index of Erectile Function

    Time frame: 12-15 months post-radical prostatectomy

    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners

  6. The International Index of Erectile Function

    Time frame: 21-24 months post-radical prostatectomy

    Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners

  7. Index of Sexual Life

    Time frame: 12-15 months post-radical prostatectomy

    Used to assess sexual desire and overall sexual satisfaction in female partners

  8. Index of Sexual Life

    Time frame: 21-24 months post-radical prostatectomy

    Used to assess sexual desire and overall sexual satisfaction in female partners

  9. Dyadic Adjustment Scale

    Time frame: 12-15 months post-radical prostatectomy

    Used to measure couple distress

  10. Dyadic Adjustment Scale

    Time frame: 21-24 months post-radical prostatectomy

    Used to measure couple distress

  11. Hospital Anxiety and Depression Scale

    Time frame: 12-15 months post-radical prostatectomy

    Used to measure anxiety and depression

  12. Hospital Anxiety and Depression Scale

    Time frame: 21-24 months post-radical prostatectomy

    Used to measure anxiety and depression

  13. Brief Profile of Mood States

    Time frame: 3-6 months post-radical prostatectomy

    Used to measure emotional distress

  14. Brief Profile of Mood States

    Time frame: 12-15 months post-radical prostatectomy

    Used to measure emotional distress

  15. Brief Profile of Mood States

    Time frame: 21-24 months post-radical prostatectomy

    Used to measure emotional distress

  16. Miller Social Intimacy Scale

    Time frame: 3-6 months post-radical prostatectomy

    Used to measure patient-partner intimacy

  17. Miller Social Intimacy Scale

    Time frame: 12-15 months post-radical prostatectomy

    Used to measure patient-partner intimacy

  18. Miller Social Intimacy Scale

    Time frame: 21-24 months post-radical prostatectomy

    Used to measure patient-partner intimacy

  19. Sternberg Triangular Love Scale

    Time frame: 3-6 months post-radical prostatectomy

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

  20. Sternberg Triangular Love Scale

    Time frame: 12-15 months post-radical prostatectomy

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

  21. Sternberg Triangular Love Scale

    Time frame: 21-24 months post-radical prostatectomy

    Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery: Steps Towards a Bio-Psychosocial Model of Treatment

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2006
Registry last updated
Dec 10, 2015

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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