Efficacy of Biofeedback in Women With Pelvic Floor Dysfunction
Condition: Pelvic Floor Dysfunction
MeSH terms: Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Recent studies have found that pelvic floor muscle training can relieve pelvic organ prolapse
      related symptoms. However, the rate of cure or improvement of symptoms with exercise
      prescription, different compliance of the patient's behavior have great differences.
      Biofeedback is an instrument used to record the biological signals ( electrical activity)
      during a voluntary pelvic floor muscle contraction and provide feedback in auditory or visual
      form (a louder sound with a stronger squeeze or an increasing number of lights on a visual
      display as the strength of the squeeze increased). Therefore, this study would explore the
      efficacy of biofeedback-assisted pelvic floor muscle training in women with pelvic floor
      dysfunction with or without organ prolapse.
    

Detailed description: 
      Treatment options for pelvic floor dysfunction (PFD) vary depending on symptom severity.
      Conservative approaches such as pelvic floor muscle (PFM) exercises, biofeedback, and
      lifestyle advice are usually suggested for urgency incontinence (UI), overactive bladder
      (OAB), and mild-to-moderate pelvic organ prolapse (POP). Conservative management remains the
      gold standard of treatment for female UI and OAB. There is Level 1, Grade A evidence
      supporting pelvic floor muscle training (PFMT) as an effective treatment for UI and OAB, and
      Grade B evidence that pelvic floor muscle training (PFMT) reduces the symptoms of urogenital
      prolapse, although topographic changes are not expected. Most of the past literatures focused
      on the effectiveness of PFMT on single disease, but seldom explored its effectiveness on
      complex disease (i.e. women presenting with more than one type of PFD). In the real world,
      some degree of POP was present in 41% to 50% of women on physical examination, but only 3% of
      patients reported symptoms such as bearing down sensation of vagina. Besides, there was a
      number of studies that assessed the efficacy of PFMT as a treatment for women with POP, but
      rarely explored its effectiveness in both subjective and objective (anatomic) improvement of
      prolapse severity.

      Biofeedback provides positive reinforcement to patients performing PFMT, therefore improves
      the quality of life of women with PFD. It can be achieved via several methods, including
      electromyography (EMG), manometry, or ultrasonography. A systematic review confirmed the
      benefit of adding of biofeedback to PFMT, but it was not clear whether this was the effect
      was related to another variable, such as the amount of health professional contact rather
      than the biofeedback.
    

Intervention name(s): A 12-week PFMT bio-assisted surface electromyographic program
Intervention type(s): Device
Intervention model: Single Group Assignment
Intervention model description: A 12-week PFMT bio-assisted surface electromyographic program in group 1(Pelvic Floor Dysfunction Without POP Stage I~II) and group 2(Pelvic Floor Dysfunction With POP Stage I~II)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic floor dysfunction; pelvic floor muscle training; pelvic organ prolapse; surface electromyographic program