Investigation of continence, sexual- and bowel function after radical surgery for bladder cancer
| ISRCTN | ISRCTN42949068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42949068 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | N/A |
| Sponsor | Lund University |
| Funder | MAS Cancer |
- Submission date
- 09/09/2015
- Registration date
- 07/10/2015
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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 March 2028
Who is funding the study?
MAS Cancer (Sweden)
Who is the main contact?
Dr Fredrik Liedberg
fredrik.liedberg@skane.se
Contact information
Scientific
Department of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02 Malmö
Sweden
| Phone | +46 40 33 10 00 |
|---|---|
| fredrik.liedberg@skane.se |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective investigational |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Functional outcomes after radical cystectomy – with emphasis on continence, sexual and rectal function – a prospective study |
| Study acronym | FORC-study |
| Study objectives | Rectal function after anterior exenteration correlates with physiologic findings post-operatively. |
| Ethics approval(s) | The Ethics Board of Lund University, 20/03/2014, ref: 2014/163 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Rectal function assessed preoperatively and postoperatively after radical cystectomy using transrectal manuvolumetry and transrectal ultrasound, before surgery (baseline) and 12 months post-operatively. |
| Completion date | 01/03/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Planned radical cystectomy for bladder cancer |
| Key exclusion criteria | Previous pelvic radiation |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 01/03/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Lund University
Malmö
201 05
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/04/2025: The recruitment end date was changed from 01/01/2026 to 01/03/2027. The overall study end date was changed from 01/01/2026 to 01/03/2028.
10/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/01/2023 to 01/01/2026.
2. The overall trial end date was changed from 01/01/2024 to 01/01/2026.
3. The intention to publish date was changed from 01/01/2020 to 01/01/2027.
08/07/2020: The intention to publish date was changed from 01/01/2020 to 31/12/2023.
22/01/2020: Internal review.
26/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/01/2021 to 01/01/2023.
2. The overall trial end date was changed from 01/01/2022 to 01/01/2024.
3. The intention to publish date was changed from 01/01/2023 to 01/01/2020.
4. IPD sharing statement added.
12/02/2018: The following changes were made:
1. Recruitment end date was changed from 01/01/2018 to 01/01/2021.
2. Overall trial end date was changed from 01/01/2019 01/01/2022.
3. Intention to publish date was changed from 01/01/2023.
