None listed
Conditions
Brief summary
the trial investigates whether the symptoms of chronic constipation can be relieved using the novel therapy of sacral nerve stimulation. A pacemaker device is surgically implanted above the sacral nerve so that an electrical stimulation can be applied to either S3 or S4. This has been shown to normalise the colonic contractions in faecal incontinence. This study intends to test wether the same stimulation will have an effect on the symptoms of chronic constipation.
Interventions
Double blind crossover trail
The surgical placement of a sacral nerve stimulator is a 1 hour operation under general anaesthetic performed in day surgery. A pacemaker is surgically placed in the buttock and a lead attached to the pacemaker is positioned along side S3 or S4.
After surgical placement of the sacral nerve stimulator . The electrical stimulation is turned on. The patient is placed on either a subsensory stimulation or a sham stimulation for a 3 week period
Setting 1- 3 weeks sham v
Double blind crossover trail The surgical placement of a sacral nerve stimulator is a 1 hour operation under general anaesthetic performed in day surgery. A pacemaker is surgically placed in the buttock and a lead attached to the pacemaker is positioned along side S3 or S4. After surgical placement of the sacral nerve stimulator . The electrical stimulation is turned on. The patient is placed on either a subsensory stimulation or a sham stimulation for a 3 week period Setting 1- 3 weeks sham v subsensory setting Device is then turned off for a 2week wash out period Wash Out (WO) 1 2weeks Setting 2- 3 weeks sham v subsensory setting WO2 2weeks Setting 3 - 3 weeks sham v suprasensory setting WO3 2weeks Setting 4 - 3 weeks sham v suprasensory setting Both supasensory and subsensory stimulation from SNS for constipation patients then enter a 2 year followup on patient preferred setting
Sponsors
Prof Ian COOK MD (SYD) FRACP
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients must be Rome II positive for constipation with unsatisfactory response to standard therapies Slow transit constipation confirmed by scintigraphic or marker study free of medication which indicates constipation as a side effect Patients complete a 3week stool diary detailing bowel movements on a daily basis over a 3 week period Eligiblty is determined on the basis of less than 2 days per week a feeling of incomplete evacuation. Rome II positive according to survey 'A study of Constipation' Slow transit constipation with a % retention greater than 9% @ 72 hours Normal ano rectal manometry
Exclusion criteria
Prior abdominal surgery(ecept cholecystectomy, appendectomey, hernia repair, splenecomy, fundoplication;oophorectomy or hysterectomy) Medications which list constipation as a side effect Other medical complications non english speaker or an inability to provide informed consent inability to make fortnightly visits to St George Hospital over a 3 month period
Outcome results
None listed