Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05772598 |
Other study ID # |
305757 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 15, 2023 |
Est. completion date |
August 2, 2023 |
Study information
Verified date |
September 2022 |
Source |
Guy's and St Thomas' NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
A cohort study comparing the novel 'Sexual Minorities and Prostate Cancer Scale' (SMACS) to
the gold standard questionnaires investigating erectile dysfunction (IIEF) and incontinence
(ICIQLUTSqol and ICIQ-UI) following robotic assisted radical prostatectomy
Description:
Prostate cancer treatments negatively impact sexual and urinary function. Prostate cancer is
increasing in incidence and through rapid uptake of the screening tool, PSA, many patients
are getting diagnosed younger and with lower risk disease. With this shift, cancer
survivorship both in its assessment and management, is becoming a growing issue as more
patients live with the after effect of prostate cancer treatments. Many tools have been
developed to assess sexual and urinary function following treatments such as the Expanded
Prostate Cancer Index (EPIC), ICIQLUTSqol or the International Index of Erectile Function
(IIEF). However, these do not capture the experience of gay, bisexual and transsexual (sexual
minority) patients.
In previous studies of heterosexual prostate cancer patients, erectile dysfunction was
reported in 51-60% after 24 months post-treatment and urinary incontinence 7-14% at 24
months. Whilst there is common ground in the obstacle for sexual recovery following surgery,
sexual minority patients face additional challenges including erections that are too weak for
anal insertive sex [], loss of ejaculate (which is a central to many sexual minority men) [],
arousal incontinence and climacturia during oral sex [] or the potential loss of sexual
pleasure in receptive anal sex []. In a recent study of 193 sexual minority prostate cancer
patients, only 12% described their overall sexual functioning as 'very good' or 'excellent'.
In a review of twelve common sexual functioning scales in prostate cancer survivors [], all
focused primarily or exclusively on erectile function and seven explicitly defined
intercourse as vaginal penetration. Thus, existing measures used in clinical research and
practice may lack validity in measuring quality of life among sexual minority patients. This
not only fails to consider these aspects in the sexual minority survival of cancer but also
under reports the scale of the problem in the literature.
Radical prostatectomy is a main treatment for low-intermediate risk prostate cancer and at
Guy's and St Thomas's, surgeons undertake around 300/year. The investigators follow these
patients up with IIEF at 3, 6, 12 and 24 months following their surgery as standard.
The Restore Group, has developed the Sexual Minorities and Prostate Cancer Scale (SMACS).
This study used 401 sexual minority patients whom completed an online battery of urinary and
sexual functioning including a new 37-item instrument about their sexual functioning post
treatment for prostate cancer. Confirmatory factor analysis was used to determine the
construct validity with three subscales revealed: sexual distress, urinary incontinence in
sex and problematic receptive anal sex. Cronbach's alphas ranged 0.86-0.93. For criterion
validity, sexual distress correlated strongly with EPIC sexual function and bother scores.
Urinary incontinence in sex correlated weakly with EPIC sexual function and bother
(r=0.10-0.19). Problematic receptive anal sex was weakly correlated with each EPIC scale
(r=0.12-0.29).
Whilst it is important to develop a tool that properly addresses sexual minority patients'
sexual and urinary dysfunction. The goal moving forward should be an inclusive questionnaire
that can be used no matter their sexual preference. This study aims to address this by
validating this new questionnaire in our post-prostatectomy cohort that will consist of
sexual majority and minority patients.