Chronic (Idiopathic) constipation Digestive System Constipation
Conditions
Interventions
Sacral nerve stimulation using a tined lead as an extended testing phase to evaluate the predictive value of this form of testing by comparing the long-term (6 months) response to permanent sacral ner
Sponsors
County Durham and Darlington NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females age 18 years or older 2. Constipation according to the ROME III* criteria for functional constipation 3. Constipation predominant irritable bowel syndrome (IBS-C) 4. Unknown (idiopathic) aetiology of constipation, as determined by the clinician 5. Symptoms not adequately relieved by the standard treatments of lifestyle modification, laxatives, suppository, and enema 6. Symptoms not adequately relieved after a trial of Prucalopride 2mg once daily, given according to licence 7. The recruiting clinician must be confident that the patient understands and that the consent process is adequate. Translation services will be provided for non-English speaking patients *For research purposes the Rome III Criteria for functional constipation are accepted and will be used in the study (Drossman, 2006). Using the Rome III criteria the diagnosis of constipation requires at least 2 of the following: 1. Straining during at least 25% of defecations 2. Lumpy or hard stools in at least 25% of defecations 3. Sensation of incomplete evacuation for at least 25% of defecations 4. Sensation of anorectal obstruction/blockage for at least 25% of defecations 5. Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor) 6. Fewer than 3 defecations per week
Exclusion criteria
Exclusion criteria: 1. Age of less than 18 years 2. Patients who are not fit enough to undergo the procedure (as per clinical judgement of PI) 3. Severe psychiatric disease at study recruitment 4. Persistent diarrhoea (except when due to laxative use) 5. Uncontrolled or decompensated cardiac, respiratory, endocrine, renal, or hepatic disease; as the clinical judgement of the site PI 6. The presence of any progressive neurological disease, or any neurological disease restricting the patients mobility and independence. Patients who have a mild non-progressive neurological disease not restricting their ambulation or independence, and not causing or contributing to their constipation will not be excluded 7. Secondary causes of constipation 8. Active systemic infection, as the clinical judgement of the site PI 9. Known pregnancy, suspected pregnancy or patients wishing to conceive 10. Subjects currently participating in or within 30 days of any interventional treatment study 11. Severe incapacity of higher mental function such that informed consent cannot be achieved. This will be determined by clinical judgement 12. Severe incapacity of higher mental function or physical abilities such that questionnaires cannot accurately be completed 13. Any patients on variable or unstable doses of anti-cholinergic drug, iron supplements, antidepressant, or opioid medications are excluded *It is the clinical decision of the investigators as to the cause of secondary constipation, reiterating that this study is to investigate 'idiopathic' constipation. The assessing clinician must decide that constipation is idiopathic and that it is not secondary to chronic drug (e.g. opioid) use. Secondary causes can also include aetiologies such as congenital, metabolic, traumatic, inflammatory, ischaemic, and neoplastic in origin. Patients on stable doses (3 months of unaltered doses) of known constipating medications are considered suitable if these medications are deemed not causative (i.e. secondary) of their constipation. **In ladies of child bearing age a pregnancy test must be performed before transit studies at baseline, and participants must agree to use adequate contraception for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Using the Patient Assessment of Constipation-Symptoms (PAC-SYM), long-term (6-month) responders are classified as those who have a 0.5 reduction in PAC-SYM scores from baseline. The primary outcome measure is therefore the response rate at 6 months comparing discriminate (those who respond to active testing only) versus indiscriminate (those who respond to placebo testing or both placebo and active testing). The analysis will be performed using Fisher's exact test in SPSS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are 3 and 6 month assessments comparing discriminate with indiscriminate groups against baseline data of global assessment of symptoms: 1. PAC-SYM 2. Patient Assessment of Constipation-Quality of Life (PAC-QOL) 3. Euro-QOL & EQ-5D to calculate cost-effectiveness and QALYS. Daily diary exercise scores are calculated for symptoms on a scale that is recorded on a daily basis. This includes: 1. Pain (Abdominal pain score) 0= No pain, 1= Not very severe, 2= Quite severe, 3= Severe, 4= Very severe. 2. Spontaneous complete bowel movements (The number of times you opened your bowels spontaneously and felt empty afterwards) 3. Bloating (Bloated, distended, tight tummy)- 0= No bloating, 1= Not very much bloating, 2= Quite a lot of bloating, 3= Severe bloating, 4=Very severe bloating. 4. Strain (Need to strain to pass stool) - 0= No strain, 1= Mild strain, 2= Moderate strain, 3=Severe strain, 9= Did not open bowels today (answer of 9 is omitted from total score calculation) 5. Laxative Score (Compared with your usual laxatives the amount you took today was +1= more, 0= same, -1= less ) 6. Laxatives (have you taken any laxative medication today) 0=no, 1= yes. These separate items are totalled for one week at a time. These totals are calculated at baseline for 2 weeks, throughout the 6 weeks of TiLTS testing and for 2 further weeks at month 3 and 6 of follow-up. | — |
Countries
United Kingdom
Outcome results
None listed