Acupoint injection combined with pelvic floor rehabilitation in the treatment of postpartum pelvic floor disorders: A protocol of randomized controlled trial

Medicine (Baltimore). 2021 Jun 11;100(23):e25511. doi: 10.1097/MD.0000000000025511.

Abstract

Background: Female pelvic floor dysfunction is one of the common chronic diseases affecting women's physical and mental health. Pregnancy and delivery are one of the main causes. Pelvic floor rehabilitation is a common method for the treatment of postpartum pelvic floor dysfunction, but it has some defects. Acupoint injection has advantages in the treatment of postpartum pelvic floor dysfunction, but there is a lack of standard clinical research to verify it. Therefore, the purpose of this randomized controlled trial is to evaluate the efficacy and safety of acupoint injection combined with pelvic floor rehabilitation in the treatment of postpartum pelvic floor disorders.

Methods: This is a prospective randomized controlled trial to study the efficacy and safety of acupoints injection combined with pelvic floor rehabilitation. And it is approved by the Ethics Committee of Clinical Research of our hospital. Patients were randomly divided into observation group (acupoint injection combined with pelvic floor rehabilitation group) or control group (pelvic floor rehabilitation group alone). The patients were followed up for 8 weeks after 12 weeks of treatment. The observation indexes included: pelvic organ prolapse degree, pelvic floor muscle strength, urinary incontinence score, adverse reactions, among others. Data were analyzed using the statistical software package SPSS version 18.0.

Conclusions: This study will evaluate the efficacy and safety of acupoint injection combined with pelvic floor rehabilitation in the treatment of postpartum pelvic floor dysfunction, and provide reliable reference for the clinical application of this project.

Trial registration: OSF Registration number: DOI 10.17605/OSF.IO/VC65Z.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Acupuncture Points
  • Acupuncture Therapy / methods*
  • Exercise Therapy / methods*
  • Female
  • Humans
  • Injections
  • Pelvic Floor Disorders* / etiology
  • Pelvic Floor Disorders* / rehabilitation
  • Pelvic Floor Disorders* / therapy
  • Puerperal Disorders* / rehabilitation
  • Puerperal Disorders* / therapy
  • Treatment Outcome