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Prostate CancerSMACSNCT05772598

Validating the 'Sexual Minorities and Prostate Cancer Scale' to Gold Standard Questionnaires

An observational study of Prostate Cancer and Incontinence, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 40 to 75 years, men only
How many people
305 participants
Where
1 siteUnited Kingdom
Study dates
15 Mar 2023to 2 Aug 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • Men only
  • Adult, Older adult

Study population: Patients treated with prostatectomy for prostate cancer

Who may be able to join

  • All patients attending for prostatectomy care at our institution

Who cannot join

  • All non-English speakers

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Guys and St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A Cohort Study Comparing the Novel 'Sexual Minorities and Prostate Cancer Scale' to the Gold Standard Questionnaires Investigating Erectile Dysfunction and Incontinence Following Robotic Assisted Radical Prostatectomy

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

Read the detailed 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.

Medical subject headings
Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The score for SMACS domains for sexual dysfunction compared to gold standard PROM for erectile function (IIEF) in a post-prostatectomy population

    At a single timepoint, sexual dysfunction measured using SMACS scale and International Index of Erectile Function.

    Measured: 10 months

  2. The score for SMACS domains for incontinence compared to two gold standard PROMs for incontinence (ICIQLUTSqol, ICIQ-UI) in a post-prostatectomy population

    At a single timepoint, incontinence will be measured using SMACS scale and International Consultation on Incontinence Questionnaires: LUTSqol and ICIQ-UI.

    Measured: 10 months

Secondary outcomes (1)
  1. Acceptability questionnaire of the SMACS questionnaire

    Acceptability and ease of use will be measured by a Likert scale 7 point questionnaire

    Measured: 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start15 Mar 2023
  3. Primary completion2 Aug 2023
  4. Study completion2 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772598
Sponsor's protocol ID
305757
Acronym
SMACS
Status last verified
Sep 2022
First submitted
6 Sep 2022
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer and Incontinence, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The score for SMACS domains for sexual dysfunction compared to gold standard PROM for erectile function (IIEF) in a post-prostatectomy population (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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