Efficacy of supervised pelvic floor muscle training with a home-based biofeedback device for urinary incontinence in postpartum women: protocol for a multicentre randomised controlled trial

BMJ Open. 2023 Apr 25;13(4):e069874. doi: 10.1136/bmjopen-2022-069874.

Abstract

Introduction: Supervised pelvic floor muscle training (PFMT) of at least 3 months duration has been strongly recommended as a first-line treatment for women with stress urinary incontinence (SUI) or SUI-predominant mixed urinary incontinence (MUI), including elderly and postnatal women. However, for the treatment of SUI and MUI in postpartum women, it is currently uncertain whether supervised PFMT combined with a biofeedback device is superior to PFMT alone. Despite some supportive results, more reliable evidence is lacking.

Methods and analysis: The study is designed as a multicentre assessor-blinded parallel-group randomised controlled trial comparing the efficacy of PFMT with a home-based pressure-mediated biofeedback device (intervention group) and that of at-home PFMT alone (control group) for women with new-onset SUI or SUI-predominant MUI after delivery. Five hundred eligible women from the obstetric outpatient clinics of five tertiary hospitals will be randomly allocated (1:1) and evaluated with repeated questionnaires, physical examinations and pelvic floor assessments at baseline (pretest), 3 months, 6 months and 12 months (postintervention) during the study period. Both groups will be instructed to follow the same training protocol under 3-month supervision after randomisation. The use of a biofeedback device with a self-assessment function will be added to the PFMT regime for patients in the intervention group. The primary outcome is the self-reported severity of urinary incontinence assessed through the short form of the International Consultation on Incontinence Questionnaire-Urinary Incontinence. Secondary outcomes include pelvic muscle support and strength, symptoms of pelvic organ prolapse, quality of life, sexual function, self-efficacy and adherence.

Ethics and dissemination: Ethical approval has been received from the Peking Union Medical College Hospital ethics committee (JS-3192D). All results from the study will be submitted to international journals and international conferences.

Trial registration number: NCT05115864.

Keywords: physiology; protocols & guidelines; urogynaecology.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biofeedback, Psychology / methods
  • Exercise Therapy / methods
  • Female
  • Humans
  • Multicenter Studies as Topic
  • Pelvic Floor
  • Postpartum Period
  • Pregnancy
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Urinary Incontinence* / therapy
  • Urinary Incontinence, Stress* / therapy

Associated data

  • ClinicalTrials.gov/NCT05115864