Condition category
Cancer
Date applied
09/09/2015
Date assigned
07/10/2015
Last edited
07/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2019

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

Phase

Drug names

Primary outcome measures

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

01/01/2019

Reason abandoned

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

01/01/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital
Södra Förstadsgatan 101 Lund University
Malmö
201 05
Sweden

Sponsor information

Organisation

Institute Translational Medicine

Sponsor details

Lund University
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.

Intention to publish date

01/01/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes