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Completed

NCT Number: NCT02427230

Treatment of Urinary Incontinence in Women With Spinal Cord Injury

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Incomplete SCI graded C, D og E on ASIA Impairment Scale, sustained minimum 3 months ago
  • urinary incontinence, corresponding to a total ICIQ-UI-SF score ≥ 8

Exclusion criteria

  • Regular treatment with botox bladder injections or < 1 year since last botox injection
  • Lack of urodynamic investigation after the SCI
  • Pregnancy
  • Pacemaker
  • Lack of ability to contract the pelvic floor muscles during objective clinical examination

Treatment and study plan

Pelvic floor muscle training

Behavioral

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.

Other names: Group 1

vaginal electrical stimulator (CefarPeristim Pro)

Drug

electrical stimulation

Primary outcomes

  1. International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)

    Time frame: up to week 24

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)

    Time frame: up to week 24

  2. Urethral Pressure Reflectometry (UPR) parameters

    Time frame: up to week 24

    UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra

  3. 3 days voiding diary

    Time frame: 3 days

  4. 24 hour pad test

    Time frame: 24 hour

  5. International Spinal Cord Injury Quality of Life Basic Data Set

    Time frame: up to week 24

  6. Patient Global Index of Improvement scale (PGI-I)

    Time frame: up to week 24

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Collaborators

  • Herlev Hospital
  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study title

The Effect of Pelvic Floor Muscle Training and Neuromuscular Electrical Stimulation on Urinary Incontinence and Quality of Life in Women With Spinal Cord Injury

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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