Sa1642 USEFULNESS OF BIOFEEDBACK TRAINING WITH NOVEL HOME DEVICE FOR FECAL INCONTINENCE: A RANDOMIZED CONTROLLED STUDY Xuelian Xiang, Tanisa Patcharatrakul, Amol Sharma, Ijeoma Azih, Rachael Parr, Satish S. Rao Background: Although biofeedback therapy (BT) is effective in the treatment of fecal inconti- nence (FI), it is labor intensive, not widely available and may lose long term efficacy because of loss of practice. We hypothesized that home device assisted BT is at least as effective as office BT and report our preliminary observations. Methods: Patients with FI (at least 1 episode /week) were randomized to office BT or home BT using a novel biofeedback device (InToneMV, InControl Medical, WI, USA). Home device consists of a probe with balloon, a pump for balloon inflation, a hand hold monitor with voice guided therapy program that includes both mechanical and electrical stimulation of anal sphincters. Office BT patients practiced kegel exercise twice daily at home and had 6, one hour, weekly office BT consisting of anal strength, endurance training and coordination training for 6 weeks. Home BT patients were asked to use home device twice daily for 20 minute session. All participants kept daily stool diaries. Bowel symptoms assessed with fecal incontinence severity index (FISI), fecal incontinence and constipation assessment (FICA) and subject's global assessment (SGA). Physiological changes were assessed with anorectal manometry at baseline and post-treatment period. Responder was defined as ≥50% decrease in weekly FI episodes compared to baseline. Results: Ten (8 females, 57.3±15.2 years old) FI patients were enrolled, and 5 in each group. There were 3/5 (60%) responders in Home BT and 2/5(40%) in Office BT. In Home BT, FI symptom severity (visual analog scale, VAS) improved in all 5 (100%), compared to 2 (40%) in Office BT and was unchanged in 2 (40%) and worse in 1 (20%). Similarly, 80% reported considerable relief with Home BT compared to 20% with Office BT, and 60% reported no change with Office BT (Table 1). The mean FISI score increased and FICA score decreased in Home BT (3.8 and 2.8) and in Office BT (1.6 and 1.2). The mean anal resting, maximal squeeze and sustained squeeze pressure increases were comparable (7.26, 18.6 and 5.24 mmHg in Home BT and 18.72, 25.32 and 3.82 mmHg in Office BT respec- tively). Conclusions: Home biofeedback treatment using a voice guided program of mechani- cal and electrical stimulation appears to be a promising approach for treatment of FI, and provides comparable physiologic and somewhat better symptomatic benefit when compared to office BT. Acknowledgement: This study is supported by InControl Medical Company (unrestricted grant) and the NIH grant R 21 (Grant Number: 5R21 DK104127-02). patients' self-assessment of the treatment effect Sa1643 FECOBIONICS: A NOVEL BIONIC TEST OF ANORECTAL FUNCTION AND DEFECATION Hans Gregersen Defecation is a complex process that may easily get disturbed. Chronic constipation is a common condition affecting 63 mio. people in North America. Defecatory disorders are commonly diagnosed with rectal balloon expulsion where a bag is distended until urge to defecate followed by attempts to expel the bag. Other diagnostic tools are HRAM and defecography. In this study we used a new expulsion device named Fecobionics where multiple pressures, orientation and bending could be assessed. We aimed to characterize physiological parameters of expulsion in healthy volunteers, in particular related to pressure signatures during the expulsion. A deformable probe was constructed with 12mm outer diameter and 10cm length. The properties mimicked those of normal formed stool. It had pressure sensors at the front and rear ends and inside an 8 cm long bag mounted on the probe (figure 1). It also contained two gyroscopes for measurement of orientation and bending. The device contained all sensor electronics for recordings. Four wires were threaded inside a thin tube to the external battery and computer. The bag was distended in the rectum of 4 healthy males until urge to defecate followed by expulsion. Several experiments were done in each person. Urge to defecate was usually felt at 45-60ml volume. All could easily expel the device after bag filling and reported that it felt like a normal defecation. During expulsion all pressure transducers showed elevated pressures but rather quickly the front pressure plateaued and decreased. The rectal pressures had values of 90-170cmH 2 O during expulsion whereas the front pressure reached values between 20-50cmH 2 O above baseline rectal pressure during anal canal passage. Based on the front and rear pressure and the difference between these two pressures we managed to subdivide the pressure tracings into five phases (figure 2). The velocity calculated from the front and rear end pressure was in the range of 4-14cm sec -1 . Gyroscope data were obtained infrequently due to technical issues. Successful experiments clearly showed the shift in orientation when the device was pushed from the rectum into the anal canal, indicating that the anorectal angle could be measured. In conclusion it was possible to obtain promising data under physiological conditions. The pressure signature allowed us to define five phases during defecation and the velocity and orientation could be assessed. Based on the present study, we suggest a preferred device to be wireless with multiple pressure measurements and measurement of S-317 AGA Abstracts the anorectal angle and the trajectory using gyroscopes. Impedance planimetry may add accurate geometric data. Hence, it will be possible accurately to detect contractions and relaxations of the IAS, EAS and puborectalis during the expulsion. The fecobionics device for pressure and orientation measurements during defecation. Pressure signature during defecation demonstrating five phases during defecation. Sa1644 EFFECT OF RECTAL DISTENTION ON ANAL PRESSURES DURING SIMULATED DEFECATION IN PATIENTS WITH DEFECATORY DISORDERS Pramoda Koduru, Anam Omer, Eamonn Quigley, Leila Neshatian Background: Recent studies have questioned diagnostic accuracy of anorectal manometry in defecatory disorders (DD). Issues include the frequent observation of abnormal manometric patterns consistent with dyssynergia in healthy volunteers during simulated defecation, especially, seen in the absence of rectal distention. We hypothesized that since the urge sensation precedes defecation, rectal distention will affect anorectal pressures during simu- lated defecation and might help to more accurately identify those with DD. Aims: To assess the effect of rectal distension on anal pressure profiles during simulated defecation in patients with DD. Methods: 62 consecutive patients with Rome III DD; 54 female, age 47±14 (mean±SD), BMI (26±5.2) were studied. Simulated defecation was performed with bear-down maneuver for 20 sec, firstly, without rectal balloon distention (push 1) and, subsequently, after balloon distention to 50 ml (push 2) and 100 ml (push 3), with complete emptying of balloon in between pushes. Anorectal pressures (mmHg) were compared before and after each rectal distension with baseline pressures. We also performed sub-group analysis in relation to outcome of 50 ml water filled balloon expulsion test (BET). Results: In this cohort, the residual anal pressures were 86.6±40 in push 1. Compared to push 1, distension of rectal balloon to 50 ml resulted in a non-significant decrease in anal residual pressures to 75.9±41, p>0.05. However, decrease in residual anal pressures became significant after rectal balloon distension to 100 ml at 68.9±31, p:0.007. Percent of anal relaxation was also significantly lower in push 2 (2±38) and 3 (7±37) as compared to push 1 (21±23), p<0.01. In sub-group analysis, the decrease in residual anal pressure in push 3 was only significant among 35 patients who passed BET; among these subjects residual anal pressures were significantly lower with rectal distension to 100 ml compared to push 1. More interestingly, rate of anal relaxation in patients who passed BET did not decrease significantly in push 2 and 3, as compared to push 1. Conversely, in subjects who failed BET, rate of anal relaxation significantly decreased and paradoxically contracted in push 2 and 3. The sensory level for urge to defecate was significantly higher in patients who failed BET (137±62 vs 109±44; p:0.05). However, the first sensation (27±19 vs20±13, p:0.1) and discomfort levels (175±70 vs 157±53, p:0.3) were comparable in both groups. Conclusion: In contrary to previous studies in asymptomatic individuals, where rectal distension did not affect anal pressures during simulated defecation, we found that in patients with ROME III DD, rectal distention is associated with improved anal relaxation and becomes significant once distention has reached level of urge to defecate. This data serves to emphasize the role of sensory input in anorectal function. AGA Abstracts