Treatment of Urinary Incontinence in Women With Spinal Cord Injury

Glostrup University Hospital, Copenhagen

Status: Completed

Conditions: Spinal Cord Injury; Urinary Incontinence

Treatments: Drug: vaginal electrical stimulator (CefarPeristim Pro); Behavioral: Pelvic floor muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02427230

20.941 (Other Grant/Funding Number)

H-2-2014-113

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Pelvic floor muscle training (PFMT)

Active Comparator group

Description:

Pelvic floor muscle training daily during 12 weeks.

Treatment:

Behavioral: Pelvic floor muscle training

Behavioral: Pelvic floor muscle training

PFMT and electrical stimulation

Active Comparator group

Description:

Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.

Treatment:

Behavioral: Pelvic floor muscle training

Behavioral: Pelvic floor muscle training

Drug: vaginal electrical stimulator (CefarPeristim Pro)