NCT02427230

Treatment of Urinary Incontinence in Women With Spinal Cord Injury

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Glostrup University Hospital, Copenhagen · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury
• Urinary Incontinence

Interventions

Type	Name	Description
BEHAVIORAL	Pelvic floor muscle training	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.
BEHAVIORAL	Pelvic floor muscle training	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.
DRUG	vaginal electrical stimulator (CefarPeristim Pro)	electrical stimulation

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-04-27
• Last updated: 2017-08-22

Locations

1 site across 1 country: Denmark