Evidence map›Paper›PMID 34796435›Full record

ArticleTechniques in coloproctology2022

A novel wireless, smartphone-based biofeedback training device for functional defecatory disorders: a pilot study.

J Cheng, F Xu, L Ma, H Zhu, Y Xu, T Cao, L Zhu, J Chen

Abstract read
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In one paragraph

Article in Techniques in coloproctology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

J ChengDivision of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China.
F XuDivision of Gastroenterology, Yinzhou People's Hospital, Ningbo, China.
L MaNingbo Medkinetic Medical Device Co., Ltd, Ningbo, China.
H ZhuTranstimulation Research Inc., Oklahoma City, OK, USA.
Y XuDivision of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China.
T CaoDivision of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China.
L ZhuDivision of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China.
J ChenNingbo Medkinetic Medical Device Co., Ltd, Ningbo, China. jeffchen@medkinetic.com.ORCID http://orcid.org/0000-0002-9083-3078
Nanjing University of Chinese Medicine · CNNingbo No. 2 Hospital · CNNingbo University · CNUniversity of Nottingham Ningbo China · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional defecatory disorders (FDDs) are highly prevalent around the world. Biofeedback is an effective treatment for FDDs. Traditionally, this treatment is performed by clinicians in a limited number of hospitals because of procedure-related expenses and a need for a dedicated procedure room. To make the biofeedback therapy more widely available, we have designed a novel wireless, smartphone-based biofeedback device, with the ultimate goal of performing the therapy at home. The aim of this pilot study was to investigate whether the developed device can be employed to treat patients with FDDs in a clinical setting, prior to employing it in a home setting.

methodsFrom March 2018 to July 2018, we performed the biofeedback therapy using the newly developed wireless, smartphone-based device in patients with FDDs 30 min daily during weekdays for 2 weeks. A Visual Analogue Scale (VAS) for bowel satisfaction, Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL), and a balloon expulsion test were assessed at baseline and after the therapy.

resultsThirteen patients were recruited and ten of them (mean age 70.3 ± 8.9 years, female:male ratio: 3:7) completed the study. Spontaneous bowel movements, complete spontaneous bowel movements, and VAS were all significantly increased after the therapy compared with baseline, respectively (6.5 ± 4.3 vs. 1.5 ± 2.2, p = 0.006; 3.1 ± 2.2 vs. 0.2 ± 0.6, p = 0.002; 49.5 ± 31.0 vs. 12.0 ± 9.2, p = 0.003). There was a significant decrease in the PAC-SYM and PAC-QoL after the biofeedback therapy (0.7 ± 0.6 vs. 1.4 ± 0.3, p = 0.001; 0.7 ± 0. 6 vs. 1.5 ± 0.4, p = 0.001). The therapy reduced the balloon expulsion time significantly (83.9 ± 68.8 s vs. 160.0 ± 36.7 s, p = 0.002). No obvious adverse events related to the procedure itself occurred.

conclusionsBiofeedback training using the newly developed wireless, smartphone-based device is feasible in the clinic setting, and it seems to be a promising method for improving constipation and related symptoms in patients with FDDs. These findings could be used to develop a much-needed, home-based, suitably powered, randomized, controlled clinical trial.

Indexed as

Quality of LifeSmartphoneAgedBiofeedback, PsychologyConstipationDefecationFemaleHumansMaleMiddle AgedPilot ProjectsTreatment OutcomeConstipationFunctional defecatory disordersWireless, smartphone-based biofeedback

Identifiers

PMID34796435
OpenAlexW3213708362

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.