Condition category
Digestive System
Date applied
05/12/2012
Date assigned
10/01/2013
Last edited
10/01/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Faecal incontinence is a common disease with considerable reduction of quality of life. Sacral nerve stimulation (SNS) and anal bulking therapy (ABT) are two treatments that have been developed during the last 10 years and are now frequently used. No proper comparison has been made between the two. The aim of this study is to compares the two treatments.

Who can participate?
Adult persons with faecal incontinence. The person fills out an incontinence diary during 3 weeks. A minimum of two episodes of faecal incontinence per week is required for participation. People with specific concurrent diseases ( eg previous rectal resection, inflammatory bowel disease) cannot participate.

What does the study involve?
Participants are randomly allocated to one of two treatments (SNS or ABT). After the treatment (surgery) the patients are followed for one year. During this time they fill out incontinence diaries and a questionnaire that evaluates Quality of Life. Minor or major adverse events are recorded.

What are the possible benefits and risks of participating?
Both treatments are part of regular health care and the risks are minor. The aim of the study is just the comparison of two treatment. There is no actual benefit for the patient. He/she gets a treatment for faecal incontinence.

Where is the study run from?
Gothenburg and Uppsala, Sweden. Hopefully one or two additional centres in Sweden and/or Norway will take part.

When is the study starting and how long is it expected to run for?
The study will start during Spring 2013 and is scheduled to end in 2 to 3 years.

Who is funding the study?
HTA-center, Gothenburg and Sahgrenska University Hospital (Sweden)

Who is the main contact?
Dr Lars Börjesson
lars.g.borjesson@vgregion.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lars Börjesson

ORCID ID

Contact details

Sahlgrenska University Hospital
Department of Surgery
Gothenburg
416 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Sacral nerve stimulation vs anal bulking for faecal incontinence - a randomised controlled trial

Acronym

Study hypothesis

There is a difference in efficency between the treatments.

Ethics approval

Gothenburg University Research Ethics Committee, 04 December 2011, ref: 858-11

Study design

Multicenter interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet [Swedish]

Condition

Faecal incontinence in adults

Intervention

Two interventional arms:
1. Sacral nerve stimulation
2. Anal bulking therapy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Responding (> 50% reduction of the number of fecal incontinence episodes compared to baseline) proportion after one year after randomisation.

Secondary outcome measures

1. Change in number of faecal incontinence episodes
2. Change in deferring time
3. Change in incontinence score
4. Change in Quality of Life
5. Adverse events

Overall trial start date

01/03/2013

Overall trial end date

01/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with fecal incontinence with > or = 2 episodes of fecal incontinence/week.
2. > 18 years
3. Insufficient effect of conservative treatment (physiotherphy, diet, drugs).
4. At least one year duration of symptoms
5. At least one year after vaginal delivery
6. Ability to confirm informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Complete external sphincter defect (at least 90 degrees, whole length of the anal canal evaluated by physical examination of ultrasound).
2. Ongoing anorectal infection
3. Active inflammatory bowel disease
4. Anorectal implant.
5. Anorectal surgery within the last 12 months.
6. Mucosal prolaps (gr 3-4)
7. Rectal prolaps
8. Ongoing malignant disease
9. Ongoing immunosuppressive treatment
10. Treatment with warfarin
11. Rectal anastomosis
12. Neurologic disease (MS, ALS, Myelomeningocele etc.)
13. Previous pelvic radiotherphy
14. Ongoing anorectal pain
15. Included in other RCT
16. Pregnancy
17. Previously treated with any of the two alternatives in the study
18. Concurrent condition or disease that makes the person unsutable for the study according clinical jugement of the investigator (eg not likely to follow the study protocol).

Recruitment start date

01/03/2013

Recruitment end date

01/03/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska University Hospital
Gothenburg
416 85
Sweden

Sponsor information

Organisation

Sahlgrenska University Hospital (Sweden)

Sponsor details

Health Technology Assessment Center
Gothenburg
413 45
Sweden
hta-centrum@vgregion.se

Sponsor type

Hospital/treatment centre

Website

http://www.sahlgrenska.se/hta-centrum

Funders

Funder type

Hospital/treatment centre

Funder name

Sahgrenska University Hospital (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes