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

Completed

Conditions: Constipation
Digestive System
Other functional intestinal disorders

Registration Number: ISRCTN25945941

Lead Sponsor: Queen Mary, University of London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 20

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)

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Normalisation of rectal sensory thresholds to balloon distension (first constant sensation, defaecatory desire volume, maximum tolerable volume)<br>2. Improvement in Cleveland Clinic Constipation scores<br>3. Increase in percentage of complete bowel movements from the bowel diaries<br><br>Measured at baseline then after two weeks and then after 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Improvements in the following criteria during the stimulation period:<br>1. Quality of life using validated methods of assessing health related quality of life (SF36) and gastrointestinal related quality of life (GIQoL)<br>2. Data from bowel diaries<br><br>Measured at baseline then after two weeks and then after 4 weeks.