Use of a defecation posture-modifying device (DPMD) was associated with normalized anorectal function among a small proportion of patients with chronic constipation, a single-center study found.
Among 325 patients with a balloon expulsion time (BET) of at least 120 seconds, 16% were able to normalize their BET to under 60 seconds when the DPMD was applied during anorectal manometry (ARM), reported Borko Nojkov, MD, of the University of Michigan in Ann Arbor, and colleagues.
An additional 2.5% had their BET improve to between 60 and 120 seconds, according to the findings in .
Normalized BET with DPMD was seen in 21% of patients with normal sphincter relaxation versus 12% of those who could not relax their sphincter (P=0.03). "The ideal candidate for DPMD would have an abnormal BET but normal anal sphincter relaxation during simulated defecation on ARM," the authors noted.
DPMDs have not been studied before in such a large, well characterized cohort of adults with chronic constipation, the authors explained. By normalizing anorectal function, DPMDs simulate stool squatting evacuation by relaxing the pelvic floor while straightening the anorectal angle.
"This is a potentially major advance, since such a relatively simple device can be widely applied without any side effects, and would benefit a large number of patients with chronic constipation and evacuation disorders," said David Greenwald, MD, of Mount Sinai Hospital in New York City and president of the American College of Gastroenterology, who was not involved in this study.
Nojkov told ľֱ that approximately 40% of patients with chronic constipation "have an underlying evacuation disorder, such as dyssynergic defecation."
For the study, his group examined data on 1,796 adults with chronic constipation, indicated by , who completed the Patient Assessment of Constipation-Symptoms () questionnaire. Patients with an evacuation disorder were included if they underwent ARM and BET and had a minimum of two constipation symptoms (i.e., incomplete evacuation, hard or lumpy stools, infrequent stools, or anorectal blockage) for a minimum of 6 months.
They were divided into groups based on BET: below 60 seconds (n=989), 60-119 seconds (n=482), and 120 seconds or more (n=325). Patients were required to repeat BET testing by using a DPMD if they showed abnormal baseline BET results of ≥120 seconds. Main outcomes assessed normalization in BET with DPMD using the Squatty Potty device.
Patients with a BET of 120 seconds or more were more likely to have dyssynergic defecation (51% vs 26%, P<0.01), and were slightly younger (mean age 46 vs 48, P=0.03) compared to the other groups.
"Normalized" BET was defined by an individual's ability to expel a 50 cc balloon full of water within 60 seconds using a DPMD. Dyssynergic defecation was defined as an abnormal BET of greater than 60 seconds with inability to relax the anal sphincter in ARM testing.
Overall, most participants were women (79%), the mean BMI was about 27, and the average age was 48. About one-fourth (26%) had dyssynergic defecation.
No differences in gender or age were observed among patients who normalized their BET using a DPMD, nor was there any significant difference in mean PAC-SYM scores among patients, whether or not they were able to achieve normalized BET with DPMD.
The analysis had several limitations, the researchers acknowledged, including the single-center design and that only patients with a BET of 120 seconds or more (as opposed to 60 to 120 seconds) were allowed use of the DPMDs.
"The main question that remains to be answered is whether a DPMD can improve constipation symptoms with continued use at home," Nojkov said. "In this study, we utilized DPMD at the point of service after an initially abnormal BET and did not have participants use the device at home after testing in our laboratory."
Disclosures
Nojkov did not report any disclosures. One coauthor reported relationships with Alfasigma, Abbvie, Alnylam, Allakos, Biomerica, Commonwealth Diagnostics International, Ferring, Ironwood, Phathom, Gemelli, GI on Demand, Nestle, Modify Health, QOL Medical, RedHill, Salix/Valeant, Progenity, Ritter, Salix, Urovant, QOL Medical, Vibrant, and Takeda, as well as patents holdings related to digital manometry and a rectal expulsion device.
Primary Source
Clinical Gastroenterology and Hepatology
Koo E, et al "Can a defecation posture modifying device correct an abnormal balloon expulsion test in chronically constipated patients?" Clin Gastroenterol Hepatol 2022; DOI: 10.1016/j.cgh.2021.12.048.