Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial.

Autor: Kannan P; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: priya.kannan@polyu.edu.hk., Cheing GLY; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Fung BKY; Department Manager of Physiotherapy Department, Kwong Wah Hospital, Hong Kong., Li J; Department of Physiotherapy, Kwong Wah Hospital, Hong Kong., Leung WC; Consultant Obstetrician & Chief-of-service, Obstetrics & Gynaecology, Kwong Wah Hospital, Hong Kong., Chung RCK; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Cheung TW; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Lam LF; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Lee WY; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Wong WC; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Wong WH; Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong., Tang PYG; Obstetrics & Gynaecology, Kwong Wah Hospital, Hong Kong., Chan PKL; Department of Mechanical Engineering, The University of Hong Kong, Pokfulam, Hong Kong.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2022 Dec; Vol. 123, pp. 106991. Date of Electronic Publication: 2022 Nov 02.
DOI: 10.1016/j.cct.2022.106991
Abstrakt: Purpose: To (i) compare the acceptance of a newly developed, novel biofeedback device (PelviSense) with that of conventional biofeedback (CB) using an intravaginal probe for the treatment of stress urinary incontinence (SUI) in women, (ii) examine the feasibility and safety of using the PelviSense device as a pelvic floor muscle (PFM) training (PFMT) adjunct, and (iii) compare the PFMT adherence and effectiveness of CB, the PelviSense device, with PFMT alone for women with SUI.
Methods: An assessor-blinded, three-arm, randomized controlled pilot trial was conducted among 51 women with SUI. Women were randomly allocated to one of three study groups (PelviSense-assisted PFMT, CB-assisted PFMT, or PFMT alone [control]). Outcome measures included the International Consultation on Incontinence Questionnaire-Short Form, the 1-h pad test, and the Modified Oxford Scale.
Results: Participants in the PelviSense-assisted PFMT group expressed good device acceptance. PFMT adherence was greater in the PelviSense-assisted PFMT group than in the unassisted or CB-assisted PFMT groups. Between-groups analysis revealed significant effects on improved SUI symptoms, urine loss severity, and PFM strength for the PelviSense-assisted PFMT group compared with the CB-assisted and PFMT alone groups.
Conclusions: The pilot trial results demonstrated moderate to high PFMT adherence in the PelviSense-assisted PFMT group and supported the safety of using the PelviSense device. The preliminary results of the pilot trial showed that PelviSense-assisted PFMT was more effective for reducing SUI symptoms among women than unassisted or CB-assisted PFMT.
Trial Registration: This trial was registered in http://ClinicalTrials.gov (reference number: NCT04638348) before the recruitment of the first participant.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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