Sexual Dysfunction and Adaptation in Couples Affected by Prostate Cancer Surgery

Completed

• Conditions: Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Sexual Dysfunction

• Registration Number: NCT00335634
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-12
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semi-Structured Interview - Patient	21-24 months post-radical prostatectomy
Semi-Structured Interview - Couple	21-24 months post-radical prostatectomy
Semi-Structured Interview - Partner	21-24 months post-radical prostatectomy

Secondary Outcome Measures

Name	Time	Method
The International Index of Erectile Function	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
Dyadic Adjustment Scale	21-24 months post-radical prostatectomy	Used to measure couple distress
Miller Social Intimacy Scale	21-24 months post-radical prostatectomy	Used to measure patient-partner intimacy
Brief Profile of Mood States	21-24 months post-radical prostatectomy	Used to measure emotional distress
Index of Sexual Life	21-24 months post-radical prostatectomy	Used to assess sexual desire and overall sexual satisfaction in female partners
Hospital Anxiety and Depression Scale	21-24 months post-radical prostatectomy	Used to measure anxiety and depression
Sternberg Triangular Love Scale	21-24 months post-radical prostatectomy	Used to assess levels of intimacy (closeness and connectedness), commitment and decisions to love, and passion

Trial Locations

Locations (2)

Etobicoke General Hospital; 🇨🇦 Etobicoke, Ontario, Canada

The Prostate Centre, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada