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

April 2, 2024 updated by: Guy's and St Thomas' NHS Foundation Trust

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients treated with prostatectomy for prostate cancer

Description

Inclusion Criteria:

  • All patients attending for prostatectomy care at our institution

Exclusion Criteria:

  • All non-English speakers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At a single timepoint, sexual dysfunction measured using SMACS scale and International Index of Erectile Function.
10 months
The score for SMACS domains for incontinence compared to two gold standard PROMs for incontinence (ICIQLUTSqol, ICIQ-UI) in a post-prostatectomy population
Time Frame: 10 months
At a single timepoint, incontinence will be measured using SMACS scale and International Consultation on Incontinence Questionnaires: LUTSqol and ICIQ-UI.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability questionnaire of the SMACS questionnaire
Time Frame: 10 months
Acceptability and ease of use will be measured by a Likert scale 7 point questionnaire
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

August 2, 2023

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 305757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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