Introduction
Female sex and increasing age are risk factors for constipation. Studies have found colon transit times to be longer in women. When estrogens decrease, constipation appears or worsens among perimenopausal women. After recommendation of lifestyle changes, second-line treatment are pharmaceutical solutions such as laxatives. However, most laxative agents show limited efficacy for chronic use, especially in people with comorbid conditions or concomitant medication inducing constipation (antihypertensives, calcium supplements to prevent osteoporosis, ...) in addition to potential adverse effects.
Intermittent colonic exoperistalsis (ICE) administered with the MOWOOT medical device, is a non-invasive, non-pharmacological treatment for chronic constipation. It has been developed to facilitate natural bowel movements and reduce the side effects of laxatives, enemas, or other invasive approaches. ICE has been proven safe and effective in constipation from both neurogenic or idiopathic aetiology in a multicentric clinical trial. Here, its use among women with functional chronic constipation was evaluated.
Aims & Methods
Adult women with chronic functional constipation were recruited in 4 hospitals in Germany. The treatment consisted of using the ICE device for 15 to 30min daily, at home. Patient outcomes were self-reported through anonymous, structured feedbacks collected at baseline (F1) and after some time under ICE treatment (F2).
Results
Data resulted from n=17 women(6 aged 18-39 yr, and 11 aged 40-80 yr). Twelve of them had a previous diagnosis of slow colonic transit. The mean time of ICE treatment at F2-feedback collection was 6,60(5,21) months (min 0,5; max 16). No one reported any serious adverse event. Three patients described occasional low self-remitting adverse events which did not affect the treatment compliance.
|
| Baseline (F1)
| Treatment (F2)
| Change (F2-F1)
| P
|
Suppositories
| Yes(F1)/Same(F2)
| 12 | 1 | -11 | 0,0002 a |
No(F1)/No or Less(F2)
| 5 | 16 |
Oral Laxatives
| Yes(F1)/Same(F2)
| 15 | 6 | -9 | 0,0039 a |
No(F1)/No or Less(F2)
| 2 | 11 |
Number Bowel Movements / week
| 2,65(1,86)
| 5,75(2,97)
| 3,10
| <0,0001 b |
Time (min) / Bowel Movement
| 110,4(149,7)
| 52,4(73,0)
| -57,94
| 0,0314 b |
Average Bristol scale (1-7)
| 2,65(1,54)
| 3,75(1,73)
| 1,25
| 0,0099 c |
Results are shown as
N or mean(SD). a: Chi
2 & Fisher's exact test; b: Student's t-Test for paired values; c: Wilcoxon matched-pairs test.
Of the 12 women using suppositories at F1, 11 (92%) had reduced its use at F2, including 9 (75%) that stopped completely. Of the 15 women using oral laxatives, 9 (60%) had reduced its use, including 4 (27%) that fully stopped. Overall, 3 women (25%) had stopped both suppositories and oral laxatives, and only 1 (8%) maintained the same dose of both. In total, 80% (12/15) of women stopped or reduced some form of laxative (Table).
In addition to laxative reduction, bowel movements increased on average by more than 3 per week, fecal consistency ameliorated (Bristol scale), and time spent in each bowel movement was reduced by nearly 1h (Table).
Conclusion
The use of ICE treatment by chronically constipated adult women significantly improved their bowel function. Importantly, this amelioration was accompanied by a notable reduction in laxatives, with a high percentage of women stopping the use of suppositories.
This in-use structured feedback in the out-patient sector points to the clinical benefit of ICE treatment. Therefore, the ICE device has the potential to substitute more invasive and pharmacological approaches in bowel management strategies for women with functional constipation.
References
- Bharucha AE, Wald A. Chronic Constipation. Mayo Clin Proc. 2019 Nov;94(11):2340-2357.
- Houghton et al. Age, Gender, and Women’s Health and the Patient. Gastroenterology 2016;150:1332–1343
- McClurg, D., L. Booth, and I. Herrero-Fresneda, Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol, 2020. 11(12): p. e00267
- Special SCI units involved in recruitment: BDH Klinik, Greifswald, GE; Werner-Wicker-Klinic, Bad Wildungen, GE; Zentralkinik, Bad Berka, GE; Klinken Beelitz, Beelitz-Heilstätten, GE.
Disclosure
IHF works as CSO at MOWOOT, USMIMA S.L., the manufacturer of the ICE device. The author would like to thank Dr J. Bremer, Dr. P. Kossmehl, Dr. I. Kurze and Dr. H. Lienhard for their support in the above-mentioned SCI hospitals, and R. Müller for his support regarding the logistics of the study.