The effect of sacral nerve stimulation on the treatment of patients with constipation resulting from difficulty in evacuating the rectum

ISRCTN	ISRCTN25945941
DOI	https://doi.org/10.1186/ISRCTN25945941
Secondary identifying numbers	LREC number 06/Q0601/46, protocol dated 25/05/06 v1

Submission date: 14/08/2009
Registration date: 05/07/2011
Last edited: 20/05/2014

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Norman Williams
Scientific

Centre for Academic Surgery
The Royal London Hospital
Whitechapel Road
London
E1 1BB
United Kingdom

Study information

Study design	Single centre randomised placebo-controlled double-blind crossover pilot study
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 found in the interventions field below to request a patient information sheet
Scientific title	Prospective randomised double-blind placebo-controlled crossover study of sacral nerve stimulation in patients with severe rectal evacuatory dysfunction and rectal hyposensitivity
Study objectives	Patients with constipation secondary to a rectal evacuatory disorder and rectal hyposensation will derive symptomatic improvement, with normalisation of rectal sensory thresholds to balloon distension, following sacral nerve stimulation.
Ethics approval(s)	Redbridge and Waltham Forest Local Research Ethics Committee approved on 14th August 2006 (ref: 06/Q0601/46)
Health condition(s) or problem(s) studied	Constipation
Intervention	1. Anorectal physiology: this will take 30 minutes; patients selected for the study will be required to have full anorectal physiology investigations. This will consist of anal manometry, rectal sensory thresholds, pudendal nerve stimulation, endoanal ultrasound, defaecating proctogram and colonic transit study. 2. Implantation of the temporary sacral nerve stimulation wire - this will take up to 60 minutes and can be done under local or general anaesthetic depending on patient choice. Throughout the procedure an image intensifier will be used intermittently to take x-rays, for a total of 2 - 3 minutes. 3. Rectal sensory thresholds - this will take up to 5 minutes; subjects will have rectal sensory thresholds to balloon distension after two weeks, at the crossover period, and at the end of the trial at 4 weeks. This consists of a balloon on the end of a catheter which will be placed into the rectum through the anus. The balloon will be inflated with air and note will be made of the volume required before the subject has the first constant sensation (FCS), a sustained desire to defaecate (DDV) and the maximum volume they can tolerate (MTV). 4. Questionnaires related to quality of life (36-item short form health survey [SF36], Gaol), symptom scores (Wexner constipation scores) will be completed at the end of two weeks and then again at the end of 4 weeks Intervention is sacral nerve stimulation, each patient has this for 4 weeks in total 2 with stimulation off (ie placebo and therefore the control), 2 weeks with the stimulation on. Neither investigator or patient knows which arm of the trial they are in. The blinding is removed at the end of the 4 weeks. Contact Details for Patient Information Material: Chetan Bhan Specialist Registrar Academic Surgical Unit The Royal London Hospital London E1 1BB
Intervention type	Other
Primary outcome measure	1. Normalisation of rectal sensory thresholds to balloon distension (first constant sensation, defaecatory desire volume, maximum tolerable volume) 2. Improvement in Cleveland Clinic Constipation scores 3. Increase in percentage of complete bowel movements from the bowel diaries Measured at baseline then after two weeks and then after 4 weeks.
Secondary outcome measures	Improvements in the following criteria during the stimulation period: 1. Quality of life using validated methods of assessing health related quality of life (SF36) and gastrointestinal related quality of life (GIQoL) 2. Data from bowel diaries Measured at baseline then after two weeks and then after 4 weeks.
Overall study start date	14/08/2006
Completion date	01/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Patients aged 18 - 65 years, either sex 2. Incomplete and/or assisted evacuation 3. Idiopathic (no rectal surgery, no spinal and overt neurological history) 4. Failed maximal conventional therapy 5. Normal colonic transit and rectal diameter 6. No significant mechanical obstructive abnormality on proctography 7. Unable to evacuate greater than 60% contrast in 3 minutes 8. Rectal hyposensation (based 2/3 abnormal values of first constant sensation [FCS], defecatory desire [DDV] and maximum tolerable volume [MTV] to balloon distension)
Key exclusion criteria	1. Inability to provide informed consent 2. Severe concomitant medical conditions precluding randomisation to operative treatment 3. Neurological diseases such as diabetic neuropathy, multiple sclerosis and parkinson's disease 4. Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers 5. Congenital anorectal anomalies or absence of native rectum due to surgery 6. Present evidence of external full thickness rectal prolapse 7. Previous rectal surgery (rectopexy/resection) done less than 12 months ago (24 months for cancer) 8. Stoma in situ 9. Chronic bowel disease such as inflammatory bowel disease, chronic uncontrolled diarrhoea 10. Anatomical limitations that would prevent successful placement of electrodes 11. Pregnancy or intention to become pregnant 12. Previous experience of sacral nerve stimulation (SNS)
Date of first enrolment	14/08/2006
Date of final enrolment	01/08/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Centre for Academic Surgery

London
E1 1BB
United Kingdom

Sponsor information

Queen Mary, University of London (UK)
Government

c/o Gerry Leonard
Queen Mary's Innovation Centre
Barts and the London School of Medicine and Dentistry
Joint Research and Development Office
Lower Ground Floor
5 Walden Street
Whitechapel
London
E1 2EF
United Kingdom

Website	http://www.smd.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

University/education

Barts and the London School of Medicine and Dentistry, Queen Mary University of London (UK) - Colorectal Development Unit, Academic Surgical Unit

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No