None listed
Conditions
Brief summary
Constipation and faecal incontinence (FI) are major health problems associated with significant personal and economic burden. First line treatment for these disorders is conservative and includes dietary modification and medication. If these fail, current guidelines recommend assessing physiological abnormalities by anorectal manometry (ARM) and balloon expulsion testing (BET). The results of these are then used to guide further management of the patients, including biofeedback therapy, neuromodulation and surgical interventions. Given the central role of ARM, a relative surprisingly lack of standardization is apparent in the literature. Factors such as catheter type, study protocol and analysis of results vary widely. With regards to FI, a wide range of values is reported as ‘normal’ for anal sphincter function, and experts recommend that each unit have their own range of values for defining abnormalities. For patients with constipation, ARM and BET are required for diagnosing dyssenrgic defecation, which has been shown to be a strong predictor of biofeedback success. Nevertheless, making this diagnosis, which includes evidence of an uncoordinated defection manoeuvre, is controversial at best, with conflicting data on the specifics of the procedure and diagnosis. The sensory component of the defecation process is also slowly being elucidated. Whereas patients with constipation may display rectal hyposensitivity, patients with FI may display either hypo or hyper sensitivity. This may have implications for the treatment of these disorders, as anorectal biofeedback can be used to teach patients how to modulate their sensory thresholds, leading to improved outcomes. Notwithstanding, how best to assess for these rectal sensory abnormalities, and what are the normal cut-offs that should be used, is still unclear. We thus aim to describe the normal sensorimotor physiology as assessed by ARM in healthy volunteers. Specifically, we aim to (1) establish normal range of values for our specific equipment and protocol and (2) evaluate comparative methods for assessing sensorimotor function. These results will be used to enhance our ability to define normal and abnormal defecatory physiology and help treat future patients with these distressing chronic conditions.
Interventions
All eligible volunteers will be invited for a one hour, single visit, anorectal physiology testing. No follow up is planned. . After obtaining informed consent, patients will perform anorectal manometry (ARM) and balloon expulsion testing (BET) according to a standard protocol. Briefly, after rectal examination, a 7-lumen water-perfused manometry catheter with 0.5 cm spaced sideholes and a compliant balloon attached to the end is used (Dentsleeve International, Canada). The catheter is connected to calibrated pressure transducers and data from the pressure transducers is displayed in digital form on a computer using data conversion software (Neomedix, Sydney Australia). Each individual study comprises assessments of the following parameters: (i) resting anal sphincter pressure, (ii) maximum anal sphincter squeeze pressure, cough pressure and duration of maximum anal squeeze and (iii) rectal pressure on strain and concomitant anal relaxation or paradoxical contraction. Neurophysiology testing using surface EMG is used to asses for squeeze and anal relaxation on strain. This takes approximately 15 minutes. Sensation thresholds will be tested using two different techniques: 1- Using a 50ml syringe air continuously injected at a rate of 100ml/minute into a balloon at the end of an anorectal catheter, as is standard in the Unit 2- Using an infinitely compliant balloon continuously injected in a rapid barostat protocol, as recently been suggested to be a more reliable measure of sensation All patients will perform both techniques. In both techniques: a. The patient is told to report when they first feel the sensation of the balloon inside the rectum, which is recorded as the rectal sensitivity threshold. b. Continuing to fill the balloon with air the patient then reports when they have the urge to defecate. c. Still continuing to fill the balloon with air the patient then reports when they cannot tolerate the inflation of the balloon any more, which is recorded as the maximum tolerated volume. The balloon is quickly deflated (manually or automatically) at the time of reported maximal tolerated volume or at a maximum volume of 300 ml, whatever is reached sooner. Sensation testing will takes approximately 25 minutes. Dyssynergic defecation using the balloon expulsion test will be tested using three different techniques: 1- Using a 50 ml water filled party balloon tied to a catheter, as is standard protocol in the Unit 2- Using a 16F Foley catheter filled with 50 ml water as has been recently suggested 3- Using a commercially available non-latex rectal balloon. All patients will perform these techniques, while the order of performance will be equally distributed. In both techniques: a. The patients try to push the balloon out while sitting over a private toilet. b. The time it takes to expel the balloon is noted. If the patient is unable to expel balloon after 3 minutes the balloon is deflated and removed. This will take approximately 10 minutes. Anorectal ultrasound will be performed as standard to ensure no major breaks in the internal or external sphincter that may undermine the normal exam. This involves 10 minutes of testing.
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria include: 1- Age between 20 and 75 2- Females 3- English speakers 4- Willingness to answer screening questionnaire 5- Willingness to give written informed consent 6- Willingness to comply with the study.
Exclusion criteria
All volunteers will be requested to answer a screening questionnaire. This will not be reimbursed. Exclusion criteria include: 1. Women lactating or pregnant 2. Definable gastrointestinal disorder based on the ROME questionnaire componenet of the screening questionnaire. . 3. Presence of overt organic anorectal disorder 4. Medications that alter motility of the GI tract such as loperamide. 5. History of anorectal or distal colon surgery. 6. History of complicated delivery 7. Previous anorectal physiological testing. 8. Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study. Psychological illness or condition will be assessed by: (1) HAD, (2) screening questionnaire questions about medical conditions, current medications, and (3) brief physician interview and discussion of PISCF before patients consent