Sacral nerve stimulation or anal bulking therapy for faecal incontinence - a comparative study

ISRCTN	ISRCTN00247992
DOI	https://doi.org/10.1186/ISRCTN00247992
Secondary identifying numbers	N/A

Submission date: 05/12/2012
Registration date: 10/01/2013
Last edited: 25/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Lars Börjesson
Scientific

Sahlgrenska University Hospital
Department of Surgery
Gothenburg
416 85
Sweden

Study information

Study design	Multicenter interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet [Swedish]
Scientific title	Sacral nerve stimulation vs anal bulking for faecal incontinence - a randomised controlled trial
Study objectives	There is a difference in efficency between the treatments.
Ethics approval(s)	Gothenburg University Research Ethics Committee, 04 December 2011, ref: 858-11
Health condition(s) or problem(s) studied	Faecal incontinence in adults
Intervention	Two interventional arms: 1. Sacral nerve stimulation 2. Anal bulking therapy
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2013
Completion date	01/03/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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).
Date of first enrolment	01/03/2013
Date of final enrolment	01/03/2015

Locations

Countries of recruitment

Sweden

Study participating centre

Sahlgrenska University Hospital

Gothenburg
416 85
Sweden

Sponsor information

Sahlgrenska University Hospital (Sweden)
Hospital/treatment centre

Health Technology Assessment Center
Gothenburg
413 45
Sweden

Email	hta-centrum@vgregion.se
Website	http://www.sahlgrenska.se/hta-centrum
"ROR"	https://ror.org/04vgqjj36

Funders

Funder type

Hospital/treatment centre

Sahgrenska University Hospital (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/06/2020: No publications found.