Treatment of Urinary Incontinence in Women With Spinal Cord Injury
- Conditions
- Spinal Cord InjuryUrinary Incontinence
- Interventions
- Behavioral: Pelvic floor muscle trainingDrug: vaginal electrical stimulator (CefarPeristim Pro)
- Registration Number
- NCT02427230
- Lead Sponsor
- Glostrup University Hospital, Copenhagen
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pelvic floor muscle training (PFMT) Pelvic floor muscle training Pelvic floor muscle training daily during 12 weeks. PFMT and electrical stimulation Pelvic floor muscle training Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks. PFMT and electrical stimulation vaginal electrical stimulator (CefarPeristim Pro) Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
- Primary Outcome Measures
Name Time Method International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF) up to week 24
- Secondary Outcome Measures
Name Time Method International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB) up to week 24 Urethral Pressure Reflectometry (UPR) parameters up to week 24 UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra
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
Trial Locations
- Locations (1)
Department of Gynaecology and Obstetrics, Herlev University Hospital
🇩🇰Herlev, Denmark