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

  • Technical Note
  • Published:
Techniques in Coloproctology Aims and scope Submit manuscript

Abstract

Background

Functional 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.

Methods

From 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.

Results

Thirteen 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.

Conclusions

Biofeedback 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.

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Funding

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Authors and Affiliations

  1. Division of Gastroenterology, Jiangsu Province Hospital of Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine), Nanjing, China

    J. Cheng, Y. Xu, T. Cao & L. Zhu

  2. Division of Gastroenterology, Yinzhou People’s Hospital, Ningbo, China

    F. Xu

  3. Ningbo Medkinetic Medical Device Co., Ltd, Ningbo, China

    L. Ma & J. Chen

  4. Transtimulation Research Inc., Oklahoma City, OK, USA

    H. Zhu

Authors
  1. J. Cheng
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  2. F. Xu
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  3. L. Ma
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  4. H. Zhu
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  5. Y. Xu
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  6. T. Cao
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  7. L. Zhu
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  8. J. Chen
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Contributions

JC and LM developed the device hardware; HZ designed the device software; JC performed the biofeedback training; FX and LZ analyzed the data; JC, YX, and TC wrote the manuscript, JC revised the manuscript.

Corresponding author

Correspondence to J. Chen.

Ethics declarations

Conflict of interest

Jianfeng Chen and Liyi Ma are employees of Ningbo Medkinetic Medical Device Co, and Hongbing Zhu is an employee of Transtimulation Research Inc, the companies that developed the biofeedback training device for this study and intended to gain regulatory approval for marketing the device in future.

Ethical approval

The study was approved by the Ethics Committee of Yinzhou People's Hospital. All patients signed a written informed consent.

Human and animal rights

This study was performed following guidelines and regulations of the Declaration of Helsinki and approved by the Ethics Committee of Yinzhou People’s Hospital.

Informed consent

All participants signed the written informed consent.

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Cheng, J., Xu, F., Ma, L. et al. A novel wireless, smartphone-based biofeedback training device for functional defecatory disorders: a pilot study. Tech Coloproctol 26, 61–65 (2022). https://doi.org/10.1007/s10151-021-02540-6

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  • DOI: https://doi.org/10.1007/s10151-021-02540-6

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