Treatment of Urinary Incontinence in Women With Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injury, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training
* Behavioral: Pelvic floor muscle training
* Drug: vaginal electrical stimulator (CefarPeristim Pro)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelvic floor muscle training (PFMT)<br>Pelvic floor muscle training daily during 12 weeks. | Behavioral: Pelvic floor muscle training<br>* 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.<br>* Other names: Group 1;|
| Active Comparator: PFMT and electrical stimulation<br>Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks. | Behavioral: Pelvic floor muscle training<br>* 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.<br>* Other names: Group 2;Drug: vaginal electrical stimulator (CefarPeristim Pro)<br>* electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF) |  | up to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB) |  | up to week 24 | 
| Urethral Pressure Reflectometry (UPR) parameters | UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra | up to week 24 | 
| 3 days voiding diary |  | 3 days | 
| 24 hour pad test |  | 24 hour | 
| International Spinal Cord Injury Quality of Life Basic Data Set |  | up to week 24 | 
| Patient Global Index of Improvement scale (PGI-I) |  | up to week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Floor Muscle Training, Neuromuscular Electrical Stimulation, Urinary Incontinence, Spinal Cord Injury