Treatment of Urinary Incontinence in Women With Spinal Cord Injury
Condition: Spinal Cord Injury; Urinary Incontinence
MeSH terms: Spinal Cord Injuries; Urinary Incontinence; Enuresis; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and
      intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary
      incontinence and improving quality of life in women with spinal cord injury (SCI).
    

Detailed description: 
      SCI patients often experience neurogenic bladder dysfunction with neurogenic detrusor
      overactivity or areflexic bladder. Due to this, 40-50 % of the SCI population suffers from
      urinary incontinence, which often reduces the patient's quality of life.

      In order to manage the neurogenic bladder dysfunction, SCI patients use specialized bladder
      emptying methods, most frequently clean intermittent catheterization. To reduce the symptoms
      of neurogenic detrusor overactivity and urinary incontinence in patients with a SCI, medical
      anticholinergic therapy can be assessed, but the effect is sparse and many adverse effects
      have been reported. Injection of Botulinum-A toxin in the bladder has shown great potential
      in minimizing the symptoms of neurogenic detrusor overactivity and urinary incontinence,
      though it is an expensive and invasive method that needs to be repeated due to its temporary
      effect.

      PFMT and NMES of the pelvic muscles are non-invasive and cheap treatments without side
      effects and several studies have demonstrated the positive effect of intravaginal NMES and/or
      PFMT on urinary incontinence in able-bodied women as well as women with neurological
      disorders like multiple sclerosis.

      Despite the fact that NMES of weak or paralyzed striated muscles has been used for decades in
      patients suffering from SCI, to our knowledge, no study has previously investigated the
      effect of PFMT and intravaginal NMES in women with SCI.

      The aim of this study is to evaluate the effect of PFMT and intravaginal NMES on Urinary
      Incontinence and Quality of Life in women with SCI. In particular, we will investigate the
      potential additional effect of intravaginal NMES, when NMES is conducted in combination with
      PFMT.

      This study is designed as a randomized clinical trial, investigating the effect of PFMT alone
      and in combination with intravaginal NMES. We will include 40 female patients with an
      incomplete SCI and urinary incontinence. After physiotherapeutic guidance, the patients
      perform PFMT or PFMT + NMES daily at home for 12 weeks with follow-up evaluations every
      fourth week.
    

Intervention name(s): Pelvic floor muscle training; Pelvic floor muscle training; vaginal electrical stimulator (CefarPeristim Pro)
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): The intervention in group 1 consists of three private lessons in PFMT conducted by a physiotherapist every 4th week.
At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks.; The intervention in group 2 consist of three private lessons in PFMT and intravaginal NMES conducted by a physiotherapist every 4th week.
At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks.
Additionally, patients will be instructed on how to use intravaginal NMES and each patient receives a vaginal electrical stimulator (CefarPeristim Pro). The NMES settings consist of two different frequencies, 40 Hz and 10 Hz, and patients are instructed to use both settings daily for maximum 30 minutes during 12 weeks.; electrical stimulation
Other intervention name(s): Group 1; Group 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pelvic Floor Muscle Training; Neuromuscular Electrical Stimulation; Urinary Incontinence; Spinal Cord Injury