Plain English Summary
Background and study aims
Bladder cancer is one of the most common types of cancer worldwide. If the cancer has spread particularly aggressively or keeps coming back after initial treatment, a radical cystectomy may be required. A radical cystectomy is an operation where the entire bladder is removed, as well as nearby organs that may contain cancer cells, such as the prostate and vas deferens (tubes that transport sperm) in men, and the uterus and ovaries in women. Although total removal of the bladder is an effective treatment against the cancer, patients often experience long-term side effects from the surgery. One of the most pronounced after effects are problems with functional problems, namely sexual problems and urinary incontinence. Another common problem following a radical cystectomy is difficulties with bowel movements, such as difficulty passing stools or needing to go urgently. The aim of this study is to look at defecation (rectal function) in patients before and after their radical cystectomy surgery.
Who can participate?
Adults suffering from bladder cancer, with a planned radical cystectomy.
What does the study involve?
Before the planned surgery, participants are asked to complete questionnaires regarding their sexual function and continence. Additionally, pressure measurements in the rectum are taken so that rectal function can be determined. Twelve months after the patients have had their radical cystectomy, the questionnaires and function tests are repeated to find out whether the results have changed.
What are the possible benefits and risks of participating?
There are no specific benefits of participating in the study. There are no risks of participating other than the usual risks which accompany radical cystectomy.
Where is the study run from?
Skåne University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2015 to January 2024
Who is funding the study?
MAS Cancer (Sweden)
Who is the main contact?
Dr Fredrik Liedberg
fredrik.liedberg@skane.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fredrik Liedberg
ORCID ID
Contact details
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02 Malmö
Sweden
+46 40 33 10 00
fredrik.liedberg@skane.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Functional outcomes after radical cystectomy – with emphasis on continence, sexual and rectal function – a prospective study
Acronym
FORC-study
Study hypothesis
Rectal function after anterior exenteration correlates with physiologic findings post-operatively.
Ethics approval
The Ethics Board of Lund University, 20/03/2014, ref: 2014/163
Study design
Prospective investigational
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Bladder cancer treated with radical cystectomy
Intervention
Before the radical cystectomy procedure, patients complete a number of questionnaires concerning their sexual function and faecal continence. Additionally, rectal function is measured using manuvolumetry at this time. 12 months after the surgery, the questionnaires and rectal function tests are repeated.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Decline in sexual function measured using IIEF-5 questionnaire (erectile dysfunction) for male participants and FSFI (female sexual dysfunction) questionnaire for female participants before surgery (baseline) and 12 months post-operatively
2. Inontinence measured using the St Mark’s questionnaire (faecal incontinence) before surgery (baseline) and 12 months post-operatively
3. Rectal function is measured by manuvolumetry is measured by maximum closure pressure (MACP) and resting anal sphincter pressure (RASP) before surgery (baseline) and 12 months post-operatively
Secondary outcome measures
Rectal function assessed preoperatively and postoperatively after radical cystectomy using transrectal manuvolumetry and transrectal ultrasound, before surgery (baseline) and 12 months post-operatively.
Overall trial start date
01/01/2015
Overall trial end date
01/01/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over
2. Planned radical cystectomy for bladder cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
Previous pelvic radiation
Recruitment start date
01/01/2015
Recruitment end date
01/01/2023
Locations
Countries of recruitment
Sweden
Trial participating centre
Skåne University Hospital
Södra Förstadsgatan 101
Lund University
Malmö
201 05
Sweden
Sponsor information
Organisation
Lund University
Sponsor details
Institute Translational Medicine
Jan Waldenströms gata 35
Malmö
20502
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
MAS Cancer
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A publication is expected one year after study completion.
Added 26/07/2019: A subgroup analysis and first publication will be submitted beginning 2020.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2023
Participant level data
Other
Basic results (scientific)
Publication list