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

Priya Kannan; Gladys L Y Cheing; Brigitte Kim Yook Fung; Jess Li; Wing Cheong Leung; Raymond C K Chung; Tsz Wing Cheung; Lok Fan Lam; Wing Yi Lee; Wai Ching Wong; Wing Hei Wong; Pui Yin Grace Tang; Paddy K L Chan

doi:10.1016/j.cct.2022.106991

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

Contemp Clin Trials. 2022 Dec:123:106991. doi: 10.1016/j.cct.2022.106991. Epub 2022 Nov 2.

Affiliations

¹ Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: priya.kannan@polyu.edu.hk.
² Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.
³ Department Manager of Physiotherapy Department, Kwong Wah Hospital, Hong Kong.
⁴ Department of Physiotherapy, Kwong Wah Hospital, Hong Kong.
⁵ Consultant Obstetrician & Chief-of-service, Obstetrics & Gynaecology, Kwong Wah Hospital, Hong Kong.
⁶ Obstetrics & Gynaecology, Kwong Wah Hospital, Hong Kong.
⁷ Department of Mechanical Engineering, The University of Hong Kong, Pokfulam, Hong Kong.

PMID: 36332826
DOI: 10.1016/j.cct.2022.106991

Abstract

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.

Keywords: Biofeedback; NCT04638348; Pelvic floor muscle training; Randomized controlled trial; Stress urinary incontinence.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Biofeedback, Psychology
Exercise Therapy / methods
Female
Humans
Pelvic Floor / physiology
Pilot Projects
Quality of Life
Treatment Outcome
Urinary Incontinence, Stress* / therapy

Associated data

ClinicalTrials.gov/NCT04638348