None listed
Conditions
Brief summary
A pilot study to assess the effectiveness of a medical device to treat chronic constipation in adults
Interventions
A four month treatment period whereby the patient applies non invasive transabdominal gastrointestinal stimulation (TAGS) for one hour per day using a convenient garment that houses the electrodes. TAGS delivers a safe electrical stimulation to the abdomen. The stimulation parameters used are in common use by physiotherapists for treating pain (4,000hz carrier with a sweep frequency between 80 -160Hz) at a current level that is comfortable for each patient.
Sponsors
GI Therapies Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 75 with chronic functional idiopathic constipation as defined by a > 6 month history of: a) Less than or equal to two “spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment b) At least 25% of the time suffer from at least one symptoms of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation
Exclusion criteria
* Constipation secondary to endocrine causes, metabolic causes or neurological conditions * Known or suspected organic disorders of the large bowel * Serious chronic medical condition * Surgical procedure on the large bowel or rectum * Pregnancy or planning to become pregnant * Insufficient comprehension of English requiring a translator * Implanted cardiac defibrillator or pacemaker
Outcome results
None listed