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.
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
- Conditions the study is for
- Prostate Cancer, Incontinence, Erectile Dysfunction Following Radical Prostatectomy
- 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
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.
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
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)
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.
- First posted16 Mar 2023
- Study start15 Mar 2023
- Primary completion2 Aug 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05772598
- Acronym / sponsor ID
- SMACS / 305757
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients treated with prostatectomy for prostate cancer
Key inclusion criteria (1 listed)
- All patients attending for prostatectomy care at our institution
Key exclusion criteria (1 listed)
- All non-English speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Acceptability questionnaire of the SMACS questionnaire
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.