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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00335634
Other study ID # PC-05-0813
Secondary ID
Status Completed
Phase N/A
First received June 8, 2006
Last updated December 9, 2015
Start date June 2006
Est. completion date July 2009

Study information

Verified date December 2015
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Etobicoke General Hospital Etobicoke Ontario
Canada The Prostate Centre, Princess Margaret Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Semi-Structured Interview - Patient 3-6 months post-radical prostatectomy No
Primary Semi-Structured Interview - Patient 12-15 months post-radical prostatectomy No
Primary Semi-Structured Interview - Patient 21-24 months post-radical prostatectomy No
Primary Semi-Structured Interview - Partner 3-6 months post-radical prostatectomy No
Primary Semi-Structured Interview - Partner 12-15 months post-radical prostatectomy No
Primary Semi-Structured Interview - Partner 21-24 months post-radical prostatectomy No
Primary Semi-Structured Interview - Couple 3-6 months post-radical prostatectomy No
Primary Semi-Structured Interview - Couple 12-15 months post-radical prostatectomy No
Primary Semi-Structured Interview - Couple 21-24 months post-radical prostatectomy No
Secondary The International Index of Erectile Function Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners 3-6 months post-radical prostatectomy No
Secondary Index of Sexual Life Used to assess sexual desire and overall sexual satisfaction in female partners 3-6 months post-radical prostatectomy No
Secondary Dyadic Adjustment Scale Used to measure couple distress 3-6 months post-radical prostatectomy No
Secondary Hospital Anxiety and Depression Scale Used to measure anxiety and depression 3-6 months post-radical prostatectomy No
Secondary The International Index of Erectile Function Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners 12-15 months post-radical prostatectomy No
Secondary The International Index of Erectile Function Used to assess erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction in patients and male partners 21-24 months post-radical prostatectomy No
Secondary Index of Sexual Life Used to assess sexual desire and overall sexual satisfaction in female partners 12-15 months post-radical prostatectomy No
Secondary Index of Sexual Life Used to assess sexual desire and overall sexual satisfaction in female partners 21-24 months post-radical prostatectomy No
Secondary Dyadic Adjustment Scale Used to measure couple distress 12-15 months post-radical prostatectomy No
Secondary Dyadic Adjustment Scale Used to measure couple distress 21-24 months post-radical prostatectomy No
Secondary Hospital Anxiety and Depression Scale Used to measure anxiety and depression 12-15 months post-radical prostatectomy No
Secondary Hospital Anxiety and Depression Scale Used to measure anxiety and depression 21-24 months post-radical prostatectomy No
Secondary Brief Profile of Mood States Used to measure emotional distress 3-6 months post-radical prostatectomy No
Secondary Brief Profile of Mood States Used to measure emotional distress 12-15 months post-radical prostatectomy No
Secondary Brief Profile of Mood States Used to measure emotional distress 21-24 months post-radical prostatectomy No
Secondary Miller Social Intimacy Scale Used to measure patient-partner intimacy 3-6 months post-radical prostatectomy No
Secondary Miller Social Intimacy Scale Used to measure patient-partner intimacy 12-15 months post-radical prostatectomy No
Secondary Miller Social Intimacy Scale Used to measure patient-partner intimacy 21-24 months post-radical prostatectomy No
Secondary Sternberg Triangular Love Scale Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion 3-6 months post-radical prostatectomy No
Secondary Sternberg Triangular Love Scale Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion 12-15 months post-radical prostatectomy No
Secondary Sternberg Triangular Love Scale Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion 21-24 months post-radical prostatectomy No
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