NCT05772598

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

April 3, 2024

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 6, 2022

Last Update Submit

April 2, 2024

Conditions

Prostate CancerIncontinenceErectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 months

Secondary Outcomes (1)

  • Acceptability questionnaire of the SMACS questionnaire

    10 months

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with prostatectomy for prostate cancer

You may qualify if:

  • All patients attending for prostatectomy care at our institution

You may not qualify if:

  • All non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guys and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

March 16, 2023

Study Start

March 15, 2023

Primary Completion

August 2, 2023

Study Completion

August 2, 2023

Last Updated

April 3, 2024

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)